Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702273
First received: June 18, 2008
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.


Condition Intervention
In Vitro Fertilization
Drug: 150 µg Corifollitropin Alfa
Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)
Drug: Placebo for Corifollitropin Alfa
Drug: Placebo for RecFSH/Follitropin beta
Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
Drug: Ganirelix
Biological: hCG
Biological: Progesterone

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) [ Time Frame: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial ] [ Designated as safety issue: No ]
    An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.


Secondary Outcome Measures:
  • Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy [ Time Frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year) ] [ Designated as safety issue: No ]
    Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.

  • Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy [ Time Frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year) ] [ Designated as safety issue: No ]
    Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.

  • Percentage of Participants in Follow up Trial With an Ectopic Pregnancy [ Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) ] [ Designated as safety issue: No ]
    An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.

  • Percentage of Participants in Follow up Trial With a Clinical Pregnancy [ Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) ] [ Designated as safety issue: No ]
    A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.

  • Percentage of Participants in Follow up Trial With a Vital Pregnancy [ Time Frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) ] [ Designated as safety issue: No ]
    A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.

  • Percentage of Participants in Follow up Trial With an Ongoing Pregnancy [ Time Frame: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year) ] [ Designated as safety issue: No ]
    An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.


Enrollment: 344
Study Start Date: September 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
150 µg Corifollitropin Alfa
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from 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). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Drug: 150 µg Corifollitropin Alfa
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.
Drug: Placebo for RecFSH/Follitropin beta
Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections 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)
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
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
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
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.
200 IU RecFSH
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from 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 were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. 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 study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)
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
Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
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
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
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
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.

Detailed Description:

This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).

Criteria

Inclusion Criteria:

  • Participants from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle;
  • Able and willing to give informed consent.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702273     History of Changes
Other Study ID Numbers: P05716, 2004-004773-28, 38831, MK-8962-009
Study First Received: June 18, 2008
Results First Received: May 14, 2014
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
In-vitro fertilization
Controlled Ovarian Stimulation
Cumulative pregnancy data
Follow-up

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Ganirelix
Progesterone
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on August 27, 2015