NCT02158026

Brief Summary

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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

3.5 years

First QC Date

June 4, 2014

Last Update Submit

January 20, 2017

Conditions

SubfertilityAssisted Reproduction

Keywords

Follicular sensitivity indexICSIIVF

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    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 Outcomes (3)

  • Retrieved oocytes

    1 hour after ovum pick up

  • Number of embryos

    3 days after ovum pick up

  • Quality of embryos

    3 days after ovum pick up

Study Arms (1)

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

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo university hospitals

Cairo, Egypt

RECRUITING

Dar AlTeb subfertility centre

Giza, Egypt

RECRUITING

Related Publications (5)

  • Zhang N, Hao CF, Zhuang LL, Liu XY, Gu HF, Liu S, Chen ZJ. Prediction of IVF/ICSI outcome based on the follicular output rate. Reprod Biomed Online. 2013 Aug;27(2):147-53. doi: 10.1016/j.rbmo.2013.04.012. Epub 2013 May 4.

    PMID: 23768619BACKGROUND

  • Broer SL, Mol BW, Hendriks D, Broekmans FJ. The role of antimullerian hormone in prediction of outcome after IVF: comparison with the antral follicle count. Fertil Steril. 2009 Mar;91(3):705-14. doi: 10.1016/j.fertnstert.2007.12.013. Epub 2008 Mar 5.

    PMID: 18321493BACKGROUND

  • de Carvalho BR, Rosa e Silva AC, Rosa e Silva JC, dos Reis RM, Ferriani RA, Silva de Sa MF. Ovarian reserve evaluation: state of the art. J Assist Reprod Genet. 2008 Jul;25(7):311-22. doi: 10.1007/s10815-008-9241-2. Epub 2008 Aug 5.

    PMID: 18679790BACKGROUND

  • Melo MA, Garrido N, Alvarez C, Bellver J, Meseguer M, Pellicer A, Remohi J. Antral follicle count (AFC) can be used in the prediction of ovarian response but cannot predict the oocyte/embryo quality or the in vitro fertilization outcome in an egg donation program. Fertil Steril. 2009 Jan;91(1):148-56. doi: 10.1016/j.fertnstert.2007.11.042. Epub 2008 May 2.

    PMID: 18455166BACKGROUND

  • Gallot V, Berwanger da Silva AL, Genro V, Grynberg M, Frydman N, Fanchin R. Antral follicle responsiveness to follicle-stimulating hormone administration assessed by the Follicular Output RaTe (FORT) may predict in vitro fertilization-embryo transfer outcome. Hum Reprod. 2012 Apr;27(4):1066-72. doi: 10.1093/humrep/der479. Epub 2012 Jan 24.

    PMID: 22279090BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • AbdelGany MA Hassan, Mrcog, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AbdelGany MA Hassan, MRCOG, MD

CONTACT

002 01017801604abdelgany2@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

EG(2)