Evaluation of the Role of Follicular Sensitivity Index in the Prediction of Pregnancy in Women Undergoing ICSI/IVF Without Polycystic Ovarian Syndrome

January 20, 2017 updated by: AbdelGany Hassan, Cairo University

Evaluation of the Role of Follicular Sensitivity Index in the Prediction of ICSI/IVF Outcome in Women Without Polycystic Ovarian Syndrome

1000 women with infertility who are already decided to be treated with ICSI will be subjected to full history taking and clinical examination. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.

All patients will have standard pituitary down-regulation followed by (Human menopausal gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is defined as number of follicles measuring≥16mm. Follicular sensitivity index (FSI) will be calculated as: (FSI =PFC*10000/AFC*Total dose of FSH)

Study Overview

Status

Unknown

Conditions

Detailed Description

Our study is observational, we are observing data from routine measurements during IVF/ICSI. Our study does not assess IVF/ICSI as an intervention, we are evaluating the role of FSI which is calculated by observing routine measurements during the IVF/ICSI procedure.

All women fulfilling the inclusion criteria will be invited to participate in the study. A written informed consent will be taken and only women signing the consent will be included in the study. Patients included in the study will be subjected to full history taking and clinical examination including general, abdominal and gynecological examination. This will be followed by a vaginal ultrasound scan to assess uterus, ovaries and any pelvic masses.

All women will go through the usual IVF/ICSI procedure explained below, our aim is to observe the antral follicle count, the pre-ovulatory count, the total dose of FSH and calculate the FSI then correlating this with pregnancy.

All patients will have standard pituitary down-regulation protocol with GnRHa (Triptorelin 0.1mg, Decapeptyl® Ferring, Germany) day 7 after ovulation of previous cycle or on day 21 of the oral contraceptive cycles. GnRHa will be continued for 2 weeks. Human menopausal gonadotrophin(HMG) (Merional ®IBSA) 150-300 IU/day will be administered until the day of HCG administration.

On the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is defined as number of follicles measuring≥16mm. FSI will be calculated as: (FSI =PFC*10000/AFC*Total dose of FSH) FSI values will be classified into 3 categories: low, medium and high the 3 groups will be compared regarding the clinical pregnancy rate, number of retrieved oocytes, number and quality of embryos The procedure will be cancelled if less than 3 follicles 16-20 mm in size are present 12 days after starting FSH despite doses reaching 450 IU. The cycle will be also cancelled if there is risk of ovarian hyperstimulation like massive ovarian enlargement or serum estradiol exceeds 3000pg/L Transvaginal oocyte retrieval will be performed 34-36 h after the administration of HCG. Oocytes will be fertilized either via IVF or ICSI based on the couple's history. Fertilization will be assessed 16-18 h after IVF or ICSI. Embryo transfers will be performed 3 days after oocyte retrieval. No more than three embryos per patient will be transferred; vaginal tablets containing progesterone (Prontogest® IBSA) administered 400 mg/day as luteal support from the day of the oocyte retrieval. Clinical pregnancy will be defined as Visualization of an intrauterine gestational sac 5 weeks after embryo transfer.

Study Type

Observational

Enrollment (Anticipated)

1000

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
      • Cairo, Egypt
        • Recruiting
        • Cairo University Hospitals
        • Sub-Investigator:
          • Mohamed MM Kotb, MD
        • Contact:
      • Giza, Egypt
        • Recruiting
        • Dar AlTeb subfertility centre
        • Sub-Investigator:
          • Ahmed MA AwadAllah, MD
        • Contact:
          • AbdelGany MA Hassan, MRCOG, MD
          • Phone Number: 00201017801604

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

1000 women with infertility without polycystic ovarian syndrome who are already decided to be treated with ICSI will be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.

Description

Inclusion Criteria:

  • Both ovaries are present
  • Day 2 FSH <10 mIU/L
  • Day 2 Estradiol <50 pg/L

Exclusion Criteria:

  • Polycystic ovarian syndrome (PCOS)
  • Abnormalities affecting the uterine cavity
  • Uncontrolled diabetes
  • Allergy to gonadotrophins
  • Cancelled cycles during the study

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
infertility without polycystic ovarian syndrome
1000 women with infertility without polycystic ovarian syndrome who are already decided to be treated with ICSI will be recruited

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: 5 weeks after embryo transfer
FSI values will be classified into 3 categories: low, medium and high. The proportion of women achieving a clinical pregnancy will be compared among the 3 groups. Clinical pregnancy will be defined as the presence of an intra-uterine gestational sac detected by ultrasound scanning.
5 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrieved oocytes
Time Frame: 1 hour after ovum pick up
FSI values will be classified into 3 categories: low, medium and high. The number of retrieved oocytes will be compared among the 3 groups.
1 hour after ovum pick up
Number of embryos
Time Frame: 3 days after ovum pick up
FSI values will be classified into 3 categories: low, medium and high. The number of embryos will be compared among the 3 groups
3 days after ovum pick up
Quality of embryos
Time Frame: 3 days after ovum pick up
FSI values will be classified into 3 categories: low, medium and high. Embryo quality will be categorised fro 1-4 according to the symmetry of cells, cell fragmentation and the number of cells. The 3 groups will be compared regarding the quality of embryos
3 days after ovum pick up

Collaborators and Investigators

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

Sponsor

Cairo University

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

June 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sub 3

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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