Miniflare Versus Long Protocol in Poor Responders

W

Woman's Health University Hospital, Egypt

Status

Unknown

Conditions

Infertility

Treatments

Drug: HMG
Drug: Triptorelin
Drug: Combined oral contraceptive pills

Study type

Interventional

Funder types

Other

Identifiers

NCT02681536
FS090216

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Minidose long protocol
Experimental group
Description:
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.
Treatment:
Drug: HMG
Drug: Triptorelin
microdose flare protocol
Experimental group
Description:
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.
Treatment:
Drug: Combined oral contraceptive pills
Drug: HMG
Drug: Triptorelin

Trial contacts and locations

1

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Central trial contact

Dina MR Dakhly, MD

Data sourced from clinicaltrials.gov

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