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Clinical Trials/NCT04310293
NCT04310293
Unknown
Not Applicable

Novel Therapy for Poor Responders Management

Al Baraka Fertility Hospital1 site in 1 country100 target enrollmentMarch 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Poor Ovarian Response
Sponsor
Al Baraka Fertility Hospital
Enrollment
100
Locations
1
Primary Endpoint
NUMBER OF OOCYTES
Last Updated
5 years ago

Overview

Brief Summary

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are <41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of the Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU & Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before

Detailed Description

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are \<41 years old and have normal FSH concentrations. To overcome this problem several strategies have been reported, with limited success. With approval of our Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU \& Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before in their previous trials

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
August 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Al Baraka Fertility Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. Kamal Rageh

medical director

Al Baraka Fertility Hospital

Eligibility Criteria

Inclusion Criteria

  • All with AFC ≤3,
  • and they give only ≤3 oocytes in their previous cycles

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

NUMBER OF OOCYTES

Time Frame: 2 weeks

NUMBER

Study Sites (1)

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