Trial Outcomes & Findings for The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation in Poor Responders (NCT NCT02357472)
NCT ID: NCT02357472
Last Updated: 2025-06-24
Results Overview
After 12 weeks treatment, the number of oocytes obtained will be detected from the higher dose group and standard dose group
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
After taking DHEA for 12 weeks
Results posted on
2025-06-24
Participant Flow
Participant milestones
| Measure |
Standard Dose Group
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
High Dose Group
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation in Poor Responders
Baseline characteristics by cohort
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.40 years
STANDARD_DEVIATION 4.70 • n=99 Participants
|
37.68 years
STANDARD_DEVIATION 5.40 • n=107 Participants
|
38.3 years
STANDARD_DEVIATION 5.05 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: After taking DHEA for 12 weeksAfter 12 weeks treatment, the number of oocytes obtained will be detected from the higher dose group and standard dose group
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
The Number of Oocytes Obtained
|
3.82 oocytes
Standard Error 0.28
|
2.51 oocytes
Standard Error 0.22
|
SECONDARY outcome
Timeframe: After taking DHEA for 12 weeksPopulation: The patients who took DHEA for 12 weeks
Antral follicle count (AFC)
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
AFC
|
4.00 follicles
Standard Error 0.20
|
4.66 follicles
Standard Error 0.26
|
SECONDARY outcome
Timeframe: 12 weeks after taking DHEAThe change of FSH levels in the three groups.
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
Follicle Stimulating Hormone (FSH) Levels
|
12.84 IU/L
Standard Deviation 0.99
|
11.69 IU/L
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 12 weeks after taking DHEASerum E2 levels
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
E2
|
51.88 pmol/L
Standard Deviation 5.64
|
39.11 pmol/L
Standard Deviation 4.44
|
SECONDARY outcome
Timeframe: 12 weeks after taking DHEAThe number of follicles\>10mm represent for the ovarian reserve and response
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
The Number of Follicles>10mm
|
8.24 follicles
Standard Deviation 0.32
|
3.71 follicles
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: baseline and 12 weeksThe change of AMH levels in serum
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
AMH
|
3.05 ng/ml
Standard Deviation 0.42
|
1.62 ng/ml
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 12 weeks after taking DHEAOutcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
Testosterone
|
31.67 ng/dl
Standard Deviation 2.6
|
31.59 ng/dl
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: 12 weeks after taking DHEAOutcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
Dehydroepiandrosterone-Sulfide (DHEA-S)
|
2.69 ug/ml
Standard Deviation 0.24
|
1.75 ug/ml
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 12 weeks after taking DHEAOutcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
Insulin-like Growth Factor-1 (IGF-1)
|
90.87 ng/ml
Standard Deviation 6.50
|
71.85 ng/ml
Standard Deviation 4.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 12 weeksOutcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
The Number of Mature Oocytes Obtained
|
4.1 oocytes
Standard Deviation 0.24
|
1.93 oocytes
Standard Deviation 0.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeks after transferThe rate of clinical pregnancy
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
Pregnancy Rate
|
7 percentage of pregnancy
|
4 percentage of pregnancy
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after taking DHEAOutcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
the Numbers of Fertilized Embryos
|
1.70 embryos
Standard Deviation 0.17
|
1.92 embryos
Standard Deviation 0.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After taking DHEA for 12 weeksOutcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
the Numbers of Cleaved Embryos
|
1.63 embryos
Standard Deviation 0.19
|
1.89 embryos
Standard Deviation 0.23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after taking DHEAtop-quality embryos are represented for \>7cell on Day 3 and the fragments \<20%
Outcome measures
| Measure |
High Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
Standard Dose Group
n=30 Participants
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
|
|---|---|---|
|
the Numbers of Top-quality Embryos.
|
1.11 embryos
Standard Deviation 0.15
|
0.85 embryos
Standard Deviation 0.13
|
Adverse Events
High Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place