NCT04310293

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

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

First Submitted

Initial submission to the registry

March 8, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

March 8, 2020

Last Update Submit

July 7, 2020

Conditions

Poor Ovarian Response

Keywords

IVFPOOR RESPONDERSGROWTH HORMONE

Outcome Measures

Primary Outcomes (1)

  • NUMBER OF OOCYTES

    NUMBER

    2 weeks

Study Arms (1)

POOR RESPONDERS

OTHER

poor responders low AMH LOW AFC

Other: Femara,Grotwth hormone,HMG

Interventions

Femara,Grotwth hormone,HMGOTHER

NOVEL THERAPY

POOR RESPONDERS

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All with AFC ≤3,
  • AMH;≤0.5
  • and they give only ≤3 oocytes in their previous cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-BARAKA FERTILITY HOSPITAL

Manama, 15006, Bahrain

RECRUITING

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical director

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 17, 2020

Study Start

March 10, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

BA(1)