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Clinical Trials/NCT02335736
NCT02335736UnknownPhase 2

Can Antagonist Protocol be the Protocol of Choice in in Vitro Fertilization Patients?

Woman's Health University Hospital, Egypt1 site in 1 country200 target enrollmentStarted: January 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
number of oocytes collected and fertilized

Study Overview

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?

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 44 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Gonadotropins releasing hormone antagonist (Drug)

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

Intervention: Gonadotropins releasing hormone antagonist (Drug)

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

Intervention: Gonadotropins releasing hormone antagonist (Drug)

Outcomes

Primary Outcomes

number of oocytes collected and fertilized

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Woman's Health University Hospital, Egypt
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dina Mohamed Refaat Dakhly

lecturer of obstetrics and gynecology

Woman's Health University Hospital, Egypt

Study Sites (1)

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