Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

NCT00702546 | Completed Results

• 4 other identifiers: P057112006-003813-42107015MK-8962-004
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.

Conditions

In Vitro Fertilization

Keywords

In-vitro fertilization; Controlled Ovarian Stimulation; Cumulative pregnancy data; Follow-up

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

  Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.

  Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711

Secondary Outcomes (6)

• Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy

  After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

• Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy

  After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

• Percentage of Participants in Follow up Study With an Ecotopic Pregnancy

  After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

• Percentage of Participants in Follow up Study With a Clinical Pregnancy

  After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

• Percentage of Participants in Follow up Study With a Vital Pregnancy

  After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Study Arms (2)

Corifollitropin alfa 100 μg

In follow-up study, no medication or investigational product was administered. But in base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.

Drug: corifollitropin alfa; Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Drug: human chorion gonadatropin (hCG); Biological: progesterone; Drug: placebo-recFSH (follitropin alfa); Biological: open-label recFSH

recFSH 150 IU

In this follow-up study, no medication or investigational product was administered. However, in base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Biological: recFSH (follitropin alfa); Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Drug: human chorion gonadatropin (hCG); Biological: progesterone; Drug: placebo-corifollitropin alfa; Biological: open-label recFSH

Interventions

corifollitropin alfa DRUG

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

Also known as: Org 36286

Corifollitropin alfa 100 μg

recFSH (follitropin alfa) BIOLOGICAL

Daily recFSH administered under protocol P05690

Also known as: Puregon®/Follistim®

recFSH 150 IU

gonadatropin releasing hormone (GnRH) antagonist ganirelix DRUG

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

Corifollitropin alfa 100 μg; recFSH 150 IU

human chorion gonadatropin (hCG) DRUG

hCG 5,000 IU or 10,000 IU administered SC under protocol P05690

Corifollitropin alfa 100 μg; recFSH 150 IU

progesterone BIOLOGICAL

Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.

Corifollitropin alfa 100 μg; recFSH 150 IU

placebo-recFSH (follitropin alfa) DRUG

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

Corifollitropin alfa 100 μg

placebo-corifollitropin alfa DRUG

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

recFSH 150 IU

open-label recFSH BIOLOGICAL

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590

Corifollitropin alfa 100 μg; recFSH 150 IU

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women from whom embryos have been cryopreserved in base study P05690

You may qualify if:

• Participants from whom embryos have been cryopreserved in base study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;
• Able and willing to give written informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin alfa; Gonadotropin-Releasing Hormone; Progesterone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 3, 2022
• Results First Posted: May 5, 2015

Record last verified: 2022-02