What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?

Infertility Clinical Trial

Official title:

Natural Cycle Versus Stimulation With Human Menopausal Gonadotropin in Cycles With Cryopreserved Embryos

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00492934
• Other study ID #: ML2436 - 30/12/2003
• Status: Active, not recruiting
• Phase: N/A
• First received: June 26, 2007
• Last updated: September 9, 2014
• Start date: January 2004
• Est. completion date: October 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Signed informed consent.

• Women with a regular cycle (between 21 and 35 days).

• Embryos with 50% intact blastomeres after thawing.

• Embryo and endometrium are synchronized.

Exclusion Criteria:

• Embryo storage time not longer than 5 years.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• human menopausal gonadotrophins
Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation

Locations

Country	Name	City	State
Belgium	Leuven University Fertility Center	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation rate per embryo		15 days after the embryo transfer	No
Secondary	thickness of the endometrium		0-2 days before the human chorionic gonadotropin (hCG) injection	No