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Comparison Between the Role of Follicular Output Rate and Preovulatory Count in the Prediction of Pregnancy in Women With Polycystic Ovarian Syndrome Undergoing Intra Cytoplasmic Sperm Injection (ICSI)

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ClinicalTrials.gov Identifier: NCT02190006
Recruitment Status : Unknown
Verified January 2017 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : July 15, 2014
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:

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 and preovulatory count which are calculated by observing routine measurements during the IVF/ICSI procedure.

300 women with polycystic ovarian syndrome (PCOS) who are 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 follicle stimulating hormone (FSH) 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 output rate (FORT) will be calculated as: (FSI =PFC*10000/AFC*Total dose of FSH).

FORT correlation to pregnancy will be compared to that of the preovulatory count number


Condition or disease
Polycystic Ovarian Syndrome Subfertility ICSI

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 and preovulatory count which are 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, and calculate the FORT.

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 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. FSH (Fostimon ®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. FORT will be calculated as: (PFC) * 100/AFC.

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. Pregnancy will be defined as the appearance of an intrauterine gestational sac by vaginal ultrasound 5 weeks after embryo transfer.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between the Role of Follicular Output Rate and Preovulatory Count in the Prediction of Pregnancy in Women With Polycystic Ovarian Syndrome Undergoing Intra Cytoplasmic Sperm Injection (ICSI)
Study Start Date : July 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Polycystic ovarian syndrome
Women with polycystic ovarian syndrome undergoing ICSI



Primary Outcome Measures :
  1. clinical pregnancy [ Time Frame: 5 weeks after embryo transfer ]
    FORT 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. Correlation of FORT with clinical pregnancy will be compared with the correlation of preovulatory count with pregnancy using a regression analysis. Clinical pregnancy will be defined as the presence of an intra-uterine gestational sac detected by ultrasound scanning.


Secondary Outcome Measures :
  1. Number of embryos [ Time Frame: 3 days after embryo transfer ]
    Correlation between FORT and the number of embryos will be compared to the correlation of preovulatory count and the number of embryos using regression analysis.

  2. Quality of embryos [ Time Frame: 3 days after ovum pick up ]
    The correlation between FORT and the quality of embryos will be compared with the correlation of preovulatory count and the quality of embryos using regression analysis.



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.


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 women with Polycystic ovarian syndrome who are already decided to be treated with ICSI will be recruited.
Criteria

Inclusion Criteria:

  • PCOS diagnosed using the Rotterdam criteria
  • Age 20-40 years
  • Both ovaries are present
  • Day 2 FSH <10 mIU/L
  • Day 2 Estradiol<50 pg/L

Exclusion Criteria:

  • Other causes of subfertility
  • Abnormalities affecting the uterine cavity
  • Uncontrolled diabetes
  • Allergy to gonadotrophins
  • Cancelled cycles during the study

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): NCT02190006


Contacts
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Contact: AbdelGany MA Hassan, MRCOG, MD 00201017801604 abdelgany2@gmail.com

Locations
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Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany MA Hassan, MRCOG, MD    00217801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MM Hassan, MRCOG, MD         
Sub-Investigator: Mohamed MM Kotb, MD         
Dar AlTeb subfertility centre Recruiting
Giza, Egypt
Contact: AbdelGany MA Hassan, MRCOG, MD    00217801604    abdelgany2@gmail.com   
Sub-Investigator: Mohamed MM Kotb, MD         
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sub-Investigator: Ahmed MA AwadAllah, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AbdelGany MA Hassan, MRCOG, MD Cairo University
Publications:

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Responsible Party: AbdelGany Hassan, Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02190006    
Other Study ID Numbers: sub 4
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Keywords provided by AbdelGany Hassan, Cairo University:
Polycystic ovarian syndrome
Follicle output rate
preovulatory count
ICSI
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Infertility
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases