Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04539067
Recruitment Status : Not yet recruiting
First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Marwa Bahgat Tarahony, Minia University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Investigate and compare the efficacy of H FSH plus HMG Vs HMG alone on oocyte and embryo quality in IcsI patients

Condition or disease Intervention/treatment Phase
Ovarian Stimulation Drug: HHMG Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Controlled Ovarian Stimulation With H FSH and HHMg Vs HMG Alone on Oocyte and Embryo Quality in IcsI Patients
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: HMG group
Induction of ovulation from 2nd day of cycle Follow diameter of follicle When follicle 18:22mm Receive HMG
 Drug: HHMG
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 Name: 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
 Drug: HHMG
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 Name: Using HHMG for induction


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539067


Contacts
Layout table for location contacts
Contact: Marwa Ba Tarahony 01008160037 marwatarahony9@gmail.com
Contact: Kareem Ib Shaheen 01210966045

Sponsors and Collaborators
Minia University
Investigators
Layout table for investigator information
Principal Investigator: Marwa Ba Tarahony Faculty of Medicine, Minia University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Marwa Bahgat Tarahony, Eygpt Minia, Minia University
ClinicalTrials.gov Identifier: NCT04539067    
Other Study ID Numbers: 635_5/2020
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No