Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

NCT00703014 | Completed Results

• 4 other identifiers: P057122004-004772-3638821MK-8962-005
• Study Type: observational
• Target: 541
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this trial was to evaluate whether Corifollitropin Alfa 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) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).

Conditions

Pregnancy; Neonates

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)

  An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.

  Up to one day following delivery (up to 1 year)

• Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)

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

  Up to one day following delivery (up to 1 year)

• Number of Infants Born in Current Follow Up Trial Experiencing AEs

  An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.

  Up to 12 weeks following delivery (up to 1 year)

• Number of Infants in Current Follow Up Trial Experiencing SAEs

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

  Up to 12 weeks following delivery (up to 1 year)

• Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.

  The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.

  At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)

• Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.

  The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.

  At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)

Study Arms (2)

Mothers Corifollitropin Alfa 150 µg

Participants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.

Drug: Corifollitropin Alfa 150 μg; Drug: Placebo for RecFSH/Follitropin beta; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Biological: Progesterone

Mothers recFSH 200 IU

Participants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.

Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7); Drug: Placebo for Corifollitropin Alfa; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Biological: Progesterone

Interventions

Corifollitropin Alfa 150 μg DRUG

In the Base Trial P05787, 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.

Mothers Corifollitropin Alfa 150 µg

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

In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

Also known as: follitropin beta, Puregon®, Follistim®

Mothers recFSH 200 IU

Placebo for Corifollitropin Alfa DRUG

In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall.

Mothers recFSH 200 IU

Placebo for RecFSH/Follitropin beta DRUG

In the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

Mothers Corifollitropin Alfa 150 µg

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

In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

Mothers Corifollitropin Alfa 150 µg; Mothers recFSH 200 IU

Ganirelix DRUG

In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG.

Mothers Corifollitropin Alfa 150 µg; Mothers recFSH 200 IU

hCG BIOLOGICAL

In the Base Trial P05787, 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

Mothers Corifollitropin Alfa 150 µg; Mothers recFSH 200 IU

Progesterone BIOLOGICAL

In the Base Trial P05787, 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.

Mothers Corifollitropin Alfa 150 µg; Mothers recFSH 200 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 ET in Base Trial P05787 (NCT00696800) were enrolled in this trial.

You may qualify if:

• Participants who received at least one dose of either Corifollitropin Alfa or
• Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);
• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);
• Able and willing to give written informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• 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

• Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28.

  PMID: 22459628 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta; ganirelix; Progesterone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 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: July 13, 2006
• Primary Completion: April 18, 2008
• Study Completion: March 15, 2009
• Last Updated: September 19, 2024
• Results First Posted: November 24, 2014

Record last verified: 2022-02