Optimisation of follicular recruitment in IVM cycles

Phase 1

• Conditions: Infertile patients with polycystic ovaries; MedDRA version: 20.0Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000019245; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-002571-25-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-14
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

1.Subfertile patients between 18–36 years old eligible for ART treatment
2.BMI 18-30
3.Polycystic ovarian morphology of the ovaries (PCO) according to the Rotterdam criteria (at least 12 antral follicles per ovary as observed on a baseline ultrasound scan), with or without hyperandrogenism, with or without oligoamenorrhoea. In other words, patients are eligible if they have PCO morphology. A diagnosis of PCOS based on Rotterdam criteria is not compulsory.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Antral follicle count (AFC) <24
2.Anti-müllerian hormone (AMH) <3,25 in non-OCP users and <4,00 in current OCP users (using Elecsys platform (Roche Diagnostics))
3.Couples requesting PGD
4.Non-obstructive azoospermia in the male partner

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether the number of immature oocytes available for in vitro maturation of oocytes is increased after treatment with Elonva compared to Puregon.<br><br>;Secondary Objective: To investigate whether follicle recruitment (number of follicles) and follicle growth (follicle size) in subfertile patients diagnosed with polycystic ovarian morphology according to the Rotterdam ultrasonographic criteria is different after administration of Elonva 100, compared to daily injectable rFSH (Puregon 150IU/d).;Primary end point(s): The number of immature oocytes available for in vitro maturation of oocytes ;Timepoint(s) of evaluation of this end point: On the day of oocyte retrieval, which is five days after the start of ovarian stimulation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Ratio of number of follicles punctured per number of follicles counted on day 1 of stimulation (recruitment rate)<br>-Follicle sizes on the day of egg retrieval.<br>-Maturation rate (MII/OCC)<br>-Fertilization rate (2PB/MII)<br>-Rate of good quality d3-embryos<br>-Rate of good quality blastocysts<br>-Implantation rate.<br>-Clinical pregnancy rate<br>- Ongoing pregnancy rate.;Timepoint(s) of evaluation of this end point: -Follicle sizes: on the day of egg retrieval;<br>-Maturation rate (MII/OCC): after 30 hours of oocyte incubation in vitro <br>-Fertilization rate (2PB/MII): 18 hours after insemination of the oocytes with sperm using ICSI<br>-Rate of good quality d3-embryos: three days after ICSI<br>-Rate of good quality blastocysts: six days after ICSI<br>-Implantation rate: five weeks after embryo transfer<br>-Clinical pregnancy rate: five weeks after embryo transfer<br>- Ongoing pregnancy rate.