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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.

Conditions

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In Vitro Fertilization

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

corifollitropin alfa

Intervention Type DRUG

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

gonadatropin releasing hormone (GnRH) antagonist ganirelix

Intervention Type DRUG

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

human chorion gonadatropin (hCG)

Intervention Type DRUG

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

progesterone

Intervention Type 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.

placebo-recFSH (follitropin alfa)

Intervention Type DRUG

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

open-label recFSH

Intervention Type BIOLOGICAL

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

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.

recFSH (follitropin alfa)

Intervention Type BIOLOGICAL

Daily recFSH administered under protocol P05690

gonadatropin releasing hormone (GnRH) antagonist ganirelix

Intervention Type DRUG

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

human chorion gonadatropin (hCG)

Intervention Type DRUG

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

progesterone

Intervention Type 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.

placebo-corifollitropin alfa

Intervention Type DRUG

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

open-label recFSH

Intervention Type BIOLOGICAL

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

Interventions

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corifollitropin alfa

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

Intervention Type DRUG

recFSH (follitropin alfa)

Daily recFSH administered under protocol P05690

Intervention Type BIOLOGICAL

gonadatropin releasing hormone (GnRH) antagonist ganirelix

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

Intervention Type DRUG

human chorion gonadatropin (hCG)

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

Intervention Type DRUG

progesterone

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.

Intervention Type BIOLOGICAL

placebo-recFSH (follitropin alfa)

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

Intervention Type DRUG

placebo-corifollitropin alfa

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

Intervention Type DRUG

open-label recFSH

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Org 36286 Puregon®/Follistim®

Eligibility Criteria

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Inclusion Criteria

* 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.