Miniflare Versus Long Protocol in Poor Responders

NCT ID: NCT02681536

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-09-30

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Minidose long protocol

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.

Group Type: EXPERIMENTAL

Triptorelin

Intervention Type: DRUG

HMG

Intervention Type: DRUG

microdose flare protocol

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.

Group Type: EXPERIMENTAL

Triptorelin

Intervention Type: DRUG

Combined oral contraceptive pills

Intervention Type: DRUG

HMG

Intervention Type: DRUG

Interventions

Triptorelin

Intervention Type: DRUG

Combined oral contraceptive pills

Intervention Type: DRUG

HMG

Intervention Type: DRUG

Other Intervention Names

Decapeptyl; Yasmin; merional

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Dina Mohamed Refaat Dakhly

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina MR Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr el aini hospital

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina MR Dakhly, MD

Role: CONTACT

dinadakhly@gmail.com

01003498919 ext. 002

Facility Contacts

Dina M Dakhly, MD

Role: primary

Dinadakhly@gmail.com

01003498919 ext. 002

References

Siristatidis CS, Yong LN, Maheshwari A, Ray Chaudhuri Bhatta S. Gonadotropin-releasing hormone agonist protocols for pituitary suppression in assisted reproduction. Cochrane Database Syst Rev. 2025 Jan 9;1(1):CD006919. doi: 10.1002/14651858.CD006919.pub5.

Reference Type: DERIVED

PMID: 39783453 (View on PubMed)

Other Identifiers

FS090216

Identifier Type: -

Identifier Source: org_study_id