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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702546
First received: June 18, 2008
Last updated: May 4, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
In Vitro Fertilization
Drug: corifollitropin alfa
Biological: recFSH (follitropin alfa)
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
Drug: human chorion gonadatropin (hCG)
Biological: progesterone
Drug: placebo-recFSH (follitropin alfa)
Drug: placebo-corifollitropin alfa
Biological: open-label recFSH

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 107012

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 P05690 (NCT00702845), and FTET cycles in follow up study P05711 ] [ Designated as safety issue: No ]
    Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.


Secondary Outcome Measures:
  • Percentage of Participants in Follow up Study With a Miscarriage Per 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 ]
    Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.

  • Percentage of Participants in Follow up Study With a Miscarriage Per 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 ]
    Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.

  • Percentage of Participants in Follow up Study With an Ecotopic 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 Study 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 Study 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 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: 102
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: corifollitropin alfa
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
Other Name: Org 36286
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
Drug: human chorion gonadatropin (hCG)
hCG 5,000 IU or 10,000 IU administered SC under protocol P05690
Biological: 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.
Drug: placebo-recFSH (follitropin alfa)
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
Biological: open-label recFSH
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.
Biological: recFSH (follitropin alfa)
Daily recFSH administered under protocol P05690
Other Name: Puregon®/Follistim®
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
Drug: human chorion gonadatropin (hCG)
hCG 5,000 IU or 10,000 IU administered SC under protocol P05690
Biological: 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.
Drug: placebo-corifollitropin alfa
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
Biological: open-label recFSH
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590

Detailed Description:

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.

  Eligibility

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

Women from whom embryos have been cryopreserved in base study P05690

Criteria

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.

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702546     History of Changes
Other Study ID Numbers: P05711, 2006-003813-42, 107015, MK-8962-004
Study First Received: June 18, 2008
Results First Received: February 9, 2015
Last Updated: May 4, 2015
Health Authority: Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Spain: Ministry of Health and Consumption
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

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
Hormones
Progesterone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on May 21, 2015