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Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

NCT00702273 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 344

Last updated 2024-09-05

Study results available
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Summary

To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.

Conditions

  • In Vitro Fertilization

Interventions

DRUG

150 µg Corifollitropin Alfa

On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.

BIOLOGICAL

200 IU RecFSH/Follitropin beta (Days 1 to 7)

Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

DRUG

Placebo for Corifollitropin Alfa

Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.

DRUG

Placebo for RecFSH/Follitropin beta

Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

BIOLOGICAL

200 IU RecFSH/Follitropin beta (Days 8 to hCG)

From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

DRUG

Ganirelix

On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

BIOLOGICAL

hCG

When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP

BIOLOGICAL

Progesterone

On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-19
Primary Completion
2009-05-19
Completion
2009-05-31

More Related Trials

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 NCT00702273 on ClinicalTrials.gov