Evaluation of the Role of Follicular Sensitivity Index in the Prediction of IVF/ICSI Outcome

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.

Study Overview

• Status: Completed
• Conditions: Subfertility
• Intervention / Treatment: Procedure: ICSI

Detailed Description

The investigators study is a retrospective cohort study. Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) in Dar AlTeb sub-fertility center from January 2010 to December 2013 will be reviewed. All records with missing data will be excluded.

Triptorelin 0.1mg (Decapeptyl® Ferring, Germany) was used for pituitary down-regulation. It was given 7 days after the expected time of ovulation in women with regular cycles. Women with irregular cycles were given combined oral contraceptive pills and triptorelin was started on day 21 after starting the pills. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol were assessed and the antral follicular count (AFC) was assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.

Controlled ovarian hyperstimulation (COH) was started on the 2nd day of menstruation using human menopausal gonadotrophin (HMG) (Merional® IBSA, Switzerland). The initial dose ranged between 150-300 IU/day. The COH drug dose was adjusted according to the patient's response guided by number and size of the follicles in addition to serum E2 values. COH was continued until at least 3 follicles ≥17mm were obtained. This was followed by the administration of Human chorionic gonadotrophin (HCG) (Choriomon®, IBSA, Switzerland) 10000 IU. On the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal probe and the Preovulatory follicle count (PFC) was assessed, (PFC) was defined as number of follicles measuring≥16mm. FSI will be calculated as (FSI =PFC*10000/AFC*Total dose of FSH) Oocyte retrieval was guided by transvaginal ultrasound and was done 34-36 hours following HCG administration. Fertilization was done by ICSI. 16-18 hours later, fertilization was confirmed by the presence of 2 pronuclei.

The procedure was cancelled if less than 3 follicles ≥17 mm in size are present 12 days after starting FSH despite doses reaching 450 IU. The cycle was also cancelled if there is risk of ovarian hyperstimulation like massive ovarian enlargement or serum estradiol exceeds 3000pg/L The quality of embryos was assessed at day 3 according to the number and evenness of blastomeres in addition to the percentage of fragmentation. Embryos were classified into 3 groups: Excellent embryos containing 6-8 even blastomeres with <10% fragmentation, moderate embryos containing 6-8 even or uneven blastomeres with 10-20% fragmentation, and poor quality embryos containing less than 6 blastomeres or >20% fragmentation.

Embryo transfer was done on the 5th day after oocyte retrieval for couples who had IVF/ICSI. If possible, 2 embryos were transferred and cryopreservation of the remaining embryos was offered.

Luteal support was given in the form of progesterone vaginal tablets (Prontogest® IBSA, Switzerland) 400mg/day starting from the day of oocyte retrieval. A pregnancy test was done 2 weeks after embryo transfer and clinical pregnancy was defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer.

• Study Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dar AlTeb subfertility centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• IVF/ICSI

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; records of women who had ICSI will be reviewed and analysed for determining FSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of retrieved oocytes	FSI values will be classified into 3 groups: High, moderate and low. the number of retrieved oocytes will be compared among the groups	one hour after ovum pick-up

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Sub8