- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04539067
Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo
August 31, 2020 updated by: Marwa Bahgat Tarahony, Minia University
Effect of Controlled Ovarian Stimulation With H FSH and HHMg Vs HMG Alone on Oocyte and Embryo Quality in IcsI Patients
Investigate and compare the efficacy of H FSH plus HMG Vs HMG alone on oocyte and embryo quality in IcsI patients
Study Overview
Detailed Description
70 patients divided in to 2groups Group A controlled ovarian stimulation with H FSH and HHMg Group B controlled ovarian stimulation with HMG alone Results will be discussed later
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Infertil women aged from 20_35yr
- Normal utreus
- Normal ovaries
- unexplained infertility
- no endometriosis
Exclusion Criteria:
1 - poor responders to gonadotropin 2-Prior history of more than 3unsucceful ICSI 3-Any malformation of sexual organs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: HMG group
Induction of ovulation from 2nd day of cycle Follow diameter of follicle When follicle 18:22mm Receive HMG
|
Induction of ovulation from the 2nd day of cycle to 5th day then follow the diameter of follicle Use transvaginal ultrasound When diameter of follicle 18 to 22 patients receiving HMG
Other Names:
|
|
EXPERIMENTAL: H FSH plus HHMG
Follow up ovulation from the 2nd day to 5th of menstruation cycle When follicle diameter 18mm to 22mm made induction of ovulation
|
Induction of ovulation from the 2nd day of cycle to 5th day then follow the diameter of follicle Use transvaginal ultrasound When diameter of follicle 18 to 22 patients receiving HMG
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients
Time Frame: 9 months
|
Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marwa Ba Tarahony, Faculty of medicine, minia university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2020
Primary Completion (ANTICIPATED)
September 1, 2021
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
August 25, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (ACTUAL)
September 4, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 4, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 635_5/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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