NCT02335736

Brief Summary

The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients?

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 phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

January 7, 2015

Last Update Submit

February 12, 2016

Conditions

Keywords

infertility

Outcome Measures

Primary Outcomes (1)

  • number of oocytes collected and fertilized

    6 months

Study Arms (3)

Normal

ACTIVE COMPARATOR

Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC.

Drug: Gonadotropins releasing hormone antagonist

Poor responders

ACTIVE COMPARATOR

Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC

Drug: Gonadotropins releasing hormone antagonist

Polycystic ovarian disease

ACTIVE COMPARATOR

Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant(Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC

Drug: Gonadotropins releasing hormone antagonist

Interventions

Also known as: Cetrotide, Serono, Geneva, Switzerland
NormalPolycystic ovarian diseasePoor responders

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age: 20- 44 years
  • Poor responder females according to Bologna criteria
  • Polycystic ovarian disease females according to Rotterdam criteria
  • Females with infertility causes other than poor responders, or PCO; male factor or tubal block

You may not qualify if:

  • refusal to get enrolled in the study
  • cases of infertility due to severe male factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Dina M Dakhly, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Dakhly, MD

CONTACT

mohamed abdalla, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 12, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

April 1, 2016

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations