Miniflare Versus Long Protocol in Poor Responders

Study Overview
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Brief Summary
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The study is performed to compare the outcomes of two stimulation protocols, the minidose long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.

Conditions
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Infertility

Intervention / Treatment
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* Drug: Triptorelin
* Drug: Combined oral contraceptive pills
* Drug: HMG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: poor responder women who fulfilled the criteria defined by the ESHRE consensus in 2011[4]; Poor responder females are those who possess two out of these three criteria: i) Female age ≥40 years; ii) Females who have at least one previous cancelled IVF cycle; iii) POR according to AFC ≤5 or low AMH value. Exclusion Criteria: females with FSH more than 20 IU/L females with previous ovarian surgery females suffering from causes of infertility other than poor ovarian response, cases with polycystic ovaries syndrome females refusing to be enrolled in the study, females with any endocrine disorder such as: diabetes, thyroid patients with male factor of infertility.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minidose long protocol<br>Down-regulation started on day 20 of the previous cycle by GnRH agonist triptorelin (0.5 µg Decapeptyl; Ferring). On the second day of menstruation, when down regulation was confirmed (as evidenced by endometrial thickness <5 mm and/or E2 levels <50 pg/mL) using transvaginal sonography (TVS) by Voluson 730 Pro (GE, Fairfield, CT) apparatus, gonadotropin (Merional; IBSA) was commenced at an initial dose of 300-450 IU/day for the first 5 days followed by individual adjustment in Gn dose according to ovarian response and the dose of Decapeptyl 50µg/day was continued until day of HCG administration. | Drug: Triptorelin<br> <br> * Other names: Decapeptyl;Drug: HMG<br> <br> * Other names: merional;|
| Experimental: microdose flare protocol<br>OCPs drospirenone /ethinyl estradiol (Yasmin, BAYER) for not less than 21 days before starting ovarian stimulation, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by HMG IM daily (Merional, 75 IU, IBSA) 3 days later. Then the same cycle adjustment was done as the minidose long protocol. | Drug: Triptorelin<br> <br> * Other names: Decapeptyl;Drug: Combined oral contraceptive pills<br> <br> * Other names: Yasmin;Drug: HMG<br> <br> * Other names: merional;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | 6 months |