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Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles

NCT05189145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-02-02

No results posted yet for this study

Summary

Hormonal monitoring impact on overall pregnancy rate in frozen embryo transfer (FET)cycles and hence progesterone supplement adjustments remain debatable in current literature. This prospective randomized study aims to investigate the effect of monitoring and follow-up of serum progesterone, estradiol \& luteinizing hormone (LH) levels and progesterone supplement adjustments on pregnancy outcomes for FET in programmed hormonal replacement therapy cycles in comparison with ultrasound only in control group

Conditions

  • Female Infertility

Interventions

DRUG

estradiol valerate

8mg orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle then assess by ultrasound

OTHER

Hormonal monitoring progesterone, estradiol, luteinizing hormone

Serum Progesterone, estrogen \& LH measured on day 13 after priming endometrium with 8mg estradiol valerate on a daily basis beginning as early as the first day of menstrual cycle.

DIAGNOSTIC_TEST

transvaginal ultrasound examination

Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation

DRUG

Progesterone 400 Mg Vaginal Suppository

Progesterone supplements given in form of daily two vaginal prontogest suppositories400 mg each

OTHER

Hormonal monitoring progesterone and estradiol

Measuring the serum Progesterone \& Estradiol in the early morning on the day of embryo transfer an progesterone supplementation adjusted as follows: Group II A: If P4 levels \< 5ng/dl, one 100 mg intramuscular injection daily added, Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added. Group II C: If P4 levels \>10ng, continued on 400 mg prontogest suppositories twice daily

DRUG

Progesterone

group II A: 100 mg intramuscular injection daily Group II B: If P4 levels 5-10ng/dl dydrogesterone added

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Sherif Hebisha, phD · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-03-15
Completion
2021-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05189145 on ClinicalTrials.gov