Duration of GnRH-analogue Downregulation and Pregnancy Rates

Phase 4

Terminated

• Conditions: Infertility
• Interventions: Procedure: Duration of GnRH agonist downregulation

• Registration Number: NCT00436319
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The purpose of this study is to assess whether the probability of pregnancy is dependent on the duration of GnRH agonist downregulation in IVF cycles.

Detailed Description

GnRH agonists have been used extensively in assisted reproduction technologies for inhibition of gonadotropin secretion from the pituitary prior to initiation of ovarian stimulation. Administration of GnRH agonists results in the prevention of spontaneous LH surges, which lead to luteinization of the developing follicles, initiation of final oocyte maturation and a decrease in pregnancy rates.

GnRH agonists are usually administered according to two protocols: the short and long protocol.In the long protocol, downregulation with GnRH agonists is initiated either in the middle of the secretory phase, or at the beginning of the follicular phase. Stimulation of the ovaries with gonadotropins is initiated when downregulation is confirmed.

Administration of gonadotropins is usually started during the second or third week of treatment with GnRH agonists.The possibility of earlier initiation of the ovarian stimulation, if downregulation is confirmed at an earlier stage, has not been examined so far.

The purpose of this study is to assess whether the duration of pituitary downregulation with GnRH agonists, prior to initiation of ovarian stimulation with gonadotropins, has any effect on pregnancy rate, in women undergoing IVF.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Primary Completion: 2015-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• age under 39
• less than 3 previous IVF cycles
• BMI 18-29
• normal ultrasound of internal genital organs

Exclusion Criteria

• polycystic ovarian syndrome
• endometriosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Duration of GnRH agonist downregulation	In the study group (group 2) the initiation of the ovarian stimulation will be effectuated on the second day of the menstrual period.

Primary Outcome Measures

Name	Time	Method
pregnancy rate	2 years

Trial Locations

Locations (1)

Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece; 🇬🇷 Thessaloniki, Greece