MedPath

Novel Therapy for Poor Responders Management

Not Applicable
Conditions
Poor Ovarian Response
Interventions
Other: Femara,Grotwth hormone,HMG
Registration Number
NCT04310293
Lead Sponsor
Al Baraka Fertility Hospital
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

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
100
Inclusion Criteria
  • All with AFC ≤3,
  • AMH;≤0.5
  • and they give only ≤3 oocytes in their previous cycles
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
POOR RESPONDERSFemara,Grotwth hormone,HMGpoor responders low AMH LOW AFC
Primary Outcome Measures
NameTimeMethod
NUMBER OF OOCYTES2 weeks

NUMBER

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Al-BARAKA FERTILITY HOSPITAL

🇧🇭

Manama, Bahrain

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