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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: mild ovarian stimulation
* Procedure: conventional ovarian stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mild ovarian stimulation<br>100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering | Procedure: mild ovarian stimulation<br>* 100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery<br>|
| Active Comparator: conventional ovarian stimulation<br>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 | Procedure: conventional ovarian stimulation<br>* 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 with GnRH agonist long protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes (COCs) |  | at oocyte recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number/rate of participants whom the IVF cycle was cancelled |  | After the 1st week of ovarian stimulation, no oocytes at OR | 
| clinical pregnancy rate | Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention | 6 weeks | 
| live birth |  | more than 20 weeks | 
| miscarriage |  | pregnancy loss before 20 weeks of gestation, after a positive pregnancy test | 
| stimulation characteristics | total dose of gonadotropins administered, | from start of stimulation until embryo transfer | 
| cancellation rate | 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 | from start of stimulation until ET | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian stimulation, climiphene citrate, Gonadotropin-Releasing Hormone agonists/antagonists, Follicle Stimulating Hormone