NCT02317978

Brief Summary

Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) in Dar AlTeb sub-fertility center will be reviewed and the follicular sensitivity index (FSI) will be calculated and correlated with pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

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

December 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

December 12, 2014

Last Update Submit

April 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy

    FSI values will be classified into 3 groups: High, moderate and low. 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 intrauterine gestational sac 5 weeks after embryo transfer.

    5 weeks after embryo transfer

Secondary Outcomes (1)

  • Number of retrieved oocytes

    one hour after ovum pick-up

Study Arms (1)

Subfertility without polycystic ovarian syndrome

The records of all women with infertility who had IVF/ICSI without polycystic ovarian syndrome (PCO) will be reviewed

Procedure: ICSI

Interventions

ICSIPROCEDURE

records of women who had ICSI will be reviewed and analysed for determining FSI

Subfertility without polycystic ovarian syndrome

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The records of women who had IVF/ICSI without PCO will be reviewed to calculate the FSI.

You may qualify if:

  • IVF/ICSI

You may not qualify if:

  • Missing data
  • Cancelled cycles.
  • Polycystic ovarian syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dar AlTeb subfertility centre

Cairo, Egypt

Location

Related Publications (3)

  • 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
  • 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

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 17, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations