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

CompletedOBSERVATIONAL
Enrollment

541

Participants

Timeline

Start Date

July 13, 2006

Primary Completion Date

April 18, 2008

Study Completion Date

March 15, 2009

Conditions
PregnancyNeonates
Interventions
DRUG

Corifollitropin Alfa 150 μg

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.

BIOLOGICAL

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

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.

DRUG

Placebo for Corifollitropin Alfa

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.

DRUG

Placebo for RecFSH/Follitropin beta

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.

BIOLOGICAL

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

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.

DRUG

Ganirelix

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.

BIOLOGICAL

hCG

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

BIOLOGICAL

Progesterone

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.

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00703014 - Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712) | Biotech Hunter | Biotech Hunter