Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation

Phase 1

Completed

• Conditions: Infertility
• Interventions: Procedure: mild ovarian stimulation; Procedure: conventional ovarian stimulation

• Registration Number: NCT01319708
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-07
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• poor responders (age>40, previous POR, abnormal OR test)
• indication for IVF
• regular cycling patients
• BMI 19-35

Exclusion Criteria

• contraindication for clomiphene citrate use or to GnRH agonists antagonists
• BMI > 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mild ovarian stimulation	mild ovarian stimulation	100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering
conventional ovarian stimulation	conventional ovarian stimulation	300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol

Primary Outcome Measures

Name	Time	Method
number of oocytes (COCs)	at oocyte recovery

Secondary Outcome Measures

Name	Time	Method
Number/rate of participants whom the IVF cycle was cancelled	After the 1st week of ovarian stimulation, no oocytes at OR
clinical pregnancy rate	6 weeks	Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention
cancellation rate	from start of stimulation until ET	when premature ovulation was evident by the loss of follicle(s) prior to oocyte recovery, and in cases where there were no oocytes retrieved or no embryos produced for transfer and in failed fertilization
live birth	more than 20 weeks
miscarriage	pregnancy loss before 20 weeks of gestation, after a positive pregnancy test
stimulation characteristics	from start of stimulation until embryo transfer	total dose of gonadotropins administered,

Trial Locations

Locations (1)

3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit; 🇬🇷 Athens, Chaidari, Greece