Miniflare Versus Long Protocol in Poor Responders

Not Applicable

• Conditions: Infertility
• Interventions: Drug: Triptorelin; Drug: Combined oral contraceptive pills; Drug: HMG

• Registration Number: NCT02681536
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-04
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microdose flare protocol	Combined oral contraceptive pills	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.
Minidose long protocol	Triptorelin	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.
Minidose long protocol	HMG	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.
microdose flare protocol	Triptorelin	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.
microdose flare protocol	HMG	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.

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	6 months

Trial Locations

Locations (1)

Kasr el aini hospital; 🇪🇬 Cairo, Egypt