A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Number of COC
研究概览
简要总结
The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries:
- Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle stimulating hormone) concentrations above the threshold for follicle recruitment in an IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in comparison to normal daily administration of rFSH (recombinant follicle stimulating hormone, Puregon)?;
- The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media registered for clinical use: does stimulation with corifollitropin alfa versus recombinant FSH have an impact on the maturation rate and developmental capacity of the oocytes ?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subfertile patients between 18-36 years old eligible for ART treatment
- •Polycystic 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 (polycystic ovary syndrome) based on Rotterdam criteria is not compulsory.
排除标准
- •Antral follicle count (AFC) <24
- •Anti-müllerian hormone (AMH) <3,25 in non-OCP (oral contraceptive pill) users and <4,00 in current OCP users (using Elecsys platform (Roche Diagnostics))
- •Couples requesting PGD (preimplantation genetic diagnosis)
- •Non-obstructive azoospermia in the male partner
研究组 & 干预措施
Elonva
A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
干预措施: oocyte retrieval for IVM (Procedure)
Elonva
A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
干预措施: blood sampling (Procedure)
Elonva
A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
干预措施: transvaginal ultrasound scanning (Procedure)
Elonva
A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
干预措施: Corifollitropin Alfa (Drug)
Elonva
A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
干预措施: oral contraceptive pill pretreatment (Marvelon) (Drug)
Puregon
Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
干预措施: blood sampling (Procedure)
Puregon
Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
干预措施: transvaginal ultrasound scanning (Procedure)
Puregon
Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
干预措施: oocyte retrieval for IVM (Procedure)
Puregon
Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
干预措施: Follitropin beta (Drug)
Puregon
Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
干预措施: oral contraceptive pill pretreatment (Marvelon) (Drug)
结局指标
主要结局
Number of COC
时间窗: 5 days after the first gonadotropin injection (on the day of oocyte retrieval)
Number of oocyte cumulus complexes obtained on the day of oocyte retrieval.
次要结局
- Clinical pregnancy rate(At about 6 - 7 weeks gestation)
研究者
Michel De Vos
Medical director
Universitair Ziekenhuis Brussel