Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02154958
Study type Observational
Source Cairo University
Contact
Status Completed
Phase N/A
Start date May 2014
Completion date July 2016

See also
  Status Clinical Trial Phase
Completed NCT03569787 - Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire
Completed NCT03105453 - The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)
Terminated NCT02180256 - Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial N/A
Terminated NCT02197832 - A RCT on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing FET Cycles N/A
Completed NCT00971152 - Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle Phase 3
Completed NCT01569945 - Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur N/A
Recruiting NCT04064840 - GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET Phase 3
Recruiting NCT02561793 - DHEA Versus Placebo in Women With Poor Ovarian Response Phase 3
Terminated NCT02570386 - Clinical Effectiveness of Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer N/A
Completed NCT02197208 - A RCT Comparing Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in FET N/A
Completed NCT01961336 - Transdermal Testosterone Pretreatment in Poor Responders Undergoing IVF Phase 3
Completed NCT02487940 - Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure Phase 4
Completed NCT01385618 - Gene-polymorphisms Relating to Human Subfertility N/A
Completed NCT00985062 - Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization N/A
Recruiting NCT04538560 - Preimplantation Genetic Testing for Aneuploidy of Polar Bodies N/A
Completed NCT02748278 - Comparison of the Number of Oocytes Obtained Between Chinese and Caucasian Women in IVF Treatment
Completed NCT02044445 - Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval? N/A
Completed NCT02863614 - Analgesia for Endometrial Scratching N/A
Completed NCT02151006 - Does Dehydro Epiandrosterone (DHEA) Improve Pregnancy Rate in Women Undergoing IVF/ICSI With Expected Poor Ovarian Response? Phase 3
Completed NCT01067664 - Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome N/A