Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle

August 31, 2020 updated by: Alaa Fouli Gaber Ebrahim
despite the large number of papers published on COH protocols comparing the efficiency of different exogenous gonadotropins, no confirmed protocol exists, and it is not quite clear which is superior to the others.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

, the objective of the current study was to compare the efficacy of 2 different ovarian stimulation protocols, comprising hpFSH, HMG versus R-FSH on oocyte and embryo quality and IVF treatment outcome in patients undergoing IVF or intracytoplasmic sperm injection (ICSI)(4).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt
        • Recruiting
        • El neel
        • Contact:
          • Kareem shaheen
          • Phone Number: +201003957442

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

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Normal ovulatory function and normal semen analysis

Description

Inclusion Criteria:

  • 1-Aged 20-35 yr, male factor, 2-Tubal or unexplained infertility, 3-regular menstruation cycle between 21 and 35 days, 4-Normal function of uterus according to hysterosalpingography, hysteroscopy or transvaginal ultrasonography, 5-Normal ovaries according to transvaginal ultrasonography during past 6 months prior to study and compatible with normal adnexa and 6-Normal ovarian anatomy, and serum FSH level less than 8 IU/l All women showed no recognizable endometriosis according to symptoms and clinical examination in transvaginal ultrasonography or diagnostic laparoscopy. 7-7-All women have a history of unexplained infertility 8-Normal ovulatory function and normal semen analysis according to the World Health Organization criteria .

Exclusion Criteria:

  • Patients with other ovulation disorders such as hypo and hypergonadotropic, hypogonadism, hyperprolactinemia.

    2-Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous history of systemic diseases such as endocrine and metabolic disorders.

    6- Previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders).

    7-Prior history of more than 3 unsucce

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group1
Group 1(50 case) which will receive hp FSH (fostimon ibsa) (150 IU per ampoule)will be started on day 2 of menstruation and then after six days, HMG (meriofert ibsa), 150 Iu, s.c) will be added
Drug: HPFSH & HMG
. Various gonadotropin preparations
Other Names:
  • rec-F.S.H
group2
Group 2(50 case) will be treated with recombinant FSH alone (Gonal-F) (150 IU per ampoule)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients.
Time Frame: 5months
(pregnancy rate, abortion and live birth rate) in IVF patients.
5months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaa Fouli Gaber Ebrahim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2021

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (ACTUAL)

September 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 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

  • COH in ICSI

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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