Role of Follicular Output Rate in the Prediction of in Vitro Fertilization and Intracytoplasmic Sperm Injection in Women With Unexplained Infertility

Subfertility Clinical Trial

Official title:

Role of Follicular Output Rate in the Prediction of in Vitro Fertilization and Intracytoplasmic Sperm Injection Outcome in Women With Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154958
• Other study ID #: Sub 1
• Status: Completed
• Phase: N/A
• First received: May 28, 2014
• Last updated: July 28, 2016
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial 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.

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 FORT which is calculated by observing routine measurements during the IVF/ICSI procedure.

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.

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 then correlating this with pregnancy.

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. Human menopausal gonadotrophin(HMG) (Merional ®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.

FORT values will be classified into 3 categories: low, medium and high the 3 groups will be compared regarding the clinical pregnancy rate, number of retrieved oocytes, number and quality of embryos 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. Clinical pregnancy will be defined as Visualization of an intrauterine gestational sac 5 weeks after embryo transfer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Unexplained infertility

• Both ovaries are present

• Day 2 FSH <10 mIU/L

• Day 2 Estradiol <80 pg/L

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Assisted Reproduction
• Infertility
• Subfertility

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo
Egypt	Dar AlTeb subfertility centre	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. Review. — View Citation

de Carvalho BR, Rosa e Silva AC, Rosa e Silva JC, dos Reis RM, Ferriani RA, Silva de Sá 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. Review. — View Citation

Genro VK, Grynberg M, Scheffer JB, Roux I, Frydman R, Fanchin R. Serum anti-Müllerian 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. — View Citation

Melo MA, Garrido N, Alvarez C, Bellver J, Meseguer M, Pellicer A, Remohí 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Retrieved oocytes	FORT values will be classified into 3 categories: low, medium and high. The number of retrieved oocytes will be compared among the 3 groups.	1 hour after ovum pick up	No
Secondary	Number of embryos	FORT values will be classified into 3 categories: low, medium and high. The number of embryos will be compared among the 3 groups	3 days after ovum pick up	No
Secondary	Quality of embryos	FORT values will be classified into 3 categories: low, medium and high. Embryo quality will be categorised fro 1-4 according to the symmetry of cells, cell fragmentation and the number of cells. The 3 groups will be compared regarding the quality of embryos	3 days after ovum pick up	No