Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

NCT00702624 | Completed Results

• 4 other identifiers: P057102006-003812-23107014MK-8962-003
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.

Conditions

Pregnancy; Neonates

Keywords

Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up

Outcome Measures

Primary Outcomes (5)

• Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)

  The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.

  From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

• Number of Expectant Mothers Experiencing Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

• Number of Expectant Mothers Experiencing Serious AEs (SAEs)

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

  From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

• Number of Infants Experiencing AEs

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  Up to 12 weeks after birth

• Number of Infants Experiencing SAEs

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

  Up to 12 weeks after birth

Study Arms (2)

Corifollitropin alfa 100 μg

In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of 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 Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), 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; Biological: human chorion gonadotropin (hCG); Biological: progesterone; Drug: placebo-recFSH (follitropin beta); Biological: open-label recFSH (follitropin beta)

recFSH 150 IU

In follow-up study, no medication or investigational product was administered. 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 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 beta); Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Biological: human chorion gonadotropin (hCG); Biological: progesterone; Drug: placebo-corifollitropin alfa; Biological: open-label recFSH (follitropin beta)

Interventions

Corifollitropin alfa DRUG

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

Also known as: SCH 900962, MK-8962

Corifollitropin alfa 100 μg

recFSH (follitropin beta) BIOLOGICAL

Daily recFSH administered under protocol P05690

Also known as: follitropin beta, 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 gonadotropin (hCG) BIOLOGICAL

hCG 5,000 IU/USP or 10,000 IU/USP administered 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 beta) 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 (follitropin beta) BIOLOGICAL

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

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 with an ongoing pregnancy at least 10 weeks after embryo transfer in base study P05690 (NCT00702845) were enrolled in this trial.

You may qualify if:

• Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
• Able and willing to give written informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.

  PMID: 22587997 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

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

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

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: April 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 3, 2022
• Results First Posted: April 30, 2015

Record last verified: 2022-02