NCT02681536

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

February 9, 2016

Last Update Submit

March 31, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    6 months

Study Arms (2)

Minidose long protocol

EXPERIMENTAL

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: TriptorelinDrug: HMG

microdose flare protocol

EXPERIMENTAL

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: TriptorelinDrug: Combined oral contraceptive pillsDrug: HMG

Interventions

TriptorelinDRUG
Also known as: Decapeptyl
Minidose long protocolmicrodose flare protocol
Combined oral contraceptive pillsDRUG
Also known as: Yasmin
microdose flare protocol
HMGDRUG
Also known as: merional
Minidose long protocolmicrodose flare protocol

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, 12211, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39783453DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoatedrospirenone and ethinyl estradiol combinationhMG-IBSA

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Dina MR Dakhly, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina MR Dakhly, MD

CONTACT

01003498919dinadakhly@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 12, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 4, 2016

Record last verified: 2016-03

Locations

EG(1)