NCT02154958

Brief Summary

300 women with unexplained infertility who are already decided to be treated with ICSI will be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre. 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. FORT will be calculated as: (PFC) \* 100/AFC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

May 28, 2014

Last Update Submit

July 28, 2016

Conditions

SubfertilityAssisted Reproduction

Keywords

Follicular output rateIVFICSI

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    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. 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)

Unexplained infertility

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

300 women with unexplained infertility who are already decided to be treated with ICSI will be recruited

You may qualify if:

  • Unexplained infertility
  • Both ovaries are present
  • Day 2 FSH \<10 mIU/L
  • Day 2 Estradiol \<80 pg/L

You may not qualify if:

  • Known other cause of subfertility
  • Expected poor responders according to Bologna criteria (9)
  • 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

Location

Dar AlTeb subfertility centre

Giza, Egypt

Location

Related Publications (6)

  • Brandes M, Hamilton CJ, van der Steen JO, de Bruin JP, Bots RS, Nelen WL, Kremer JA. Unexplained infertility: overall ongoing pregnancy rate and mode of conception. Hum Reprod. 2011 Feb;26(2):360-8. doi: 10.1093/humrep/deq349. Epub 2010 Dec 16.

    PMID: 21163857BACKGROUND

  • 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

  • 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

  • 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

  • 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

  • Genro VK, Grynberg M, Scheffer JB, Roux I, Frydman R, Fanchin R. Serum anti-Mullerian hormone levels are negatively related to Follicular Output RaTe (FORT) in normo-cycling women undergoing controlled ovarian hyperstimulation. Hum Reprod. 2011 Mar;26(3):671-7. doi: 10.1093/humrep/deq361. Epub 2010 Dec 21.

    PMID: 21177311BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • AbdelGany MA Hassan, MRCOG, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

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

May 28, 2014

First Posted

June 4, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

EG(2)