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

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. Infertil women aged from 20_35yr
  2. Normal utreus
  3. Normal ovaries
  4. unexplained infertility
  5. 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:
  • Using HHMG for induction
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:
  • Using HHMG for induction

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.

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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