Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone Capsules (Progeffik) for Endometrial Preparation in Fresh Donated Oocytes Recipients: a Randomised, Prospective, Single-blind, Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- ongoing pregnancy rate at 12 weeks gestation
研究概览
简要总结
Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the impact on the ongoing pregnancy rate with the use of two progesterones with different administration routes, in recipients of fresh embryos from donor oocytes, undergoing endometrial preparation for fresh embryo transfer.
详细描述
Exploratory study with a control group treated according to our Service's usual therapeutic regimen for the transfer of embryos with donor oocytes.
The controlled ovarian stimulation protocol in oocyte donors is always calculated according to the standard protocol at the Bernabeu Institute. Endometrial preparation will be carried out following the standard protocol of the Bernabeu Institute as follows: the oestrogen will be administered transdermally and patients with maintained ovarian function undergo medical hypophysectomy with depot GnRH agonists administered in the mid-luteal phase of the previous cycle.
On the day of oocyte retrieval, the patient will be randomised: Group A will be administered subcutaneous progesterone 25 mg/day (Prolutex), and Group B will be administered vaginal progesterone in capsules 200 mg/3 times a day (Progeffik).
The embryo transfer will be performed on day 5 of the embryo culture (Day +5). A biochemical pregnancy test beta- hCG and the P4 analysis will be performed 14 days after oocyte retrieval.
All the cycles will be monitored according to the Department's standard criteria, using transvaginal ultrasound to assess embryonic development and endometrial thickness, as well as analytical controls.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged from 18 to 49 years (both inclusive)
- •Woman who wishes to become pregnant
- •Endometrial thickness greater 7 mm on the day of patient randomisation to one of the progesterone groups
- •Six or more donor retrieved oocytes
- •Patient programmed for fresh embryo transfer on day +5 of embryo culture
- •BMI lower than 30 Kg/m2
- •Infertility that justifies treatment with donor oocytes
- •Male with no known karyotype alterations
- •Semen by ejaculation from either the partner or from a bank
- •Uterus able to support embryo implantation and pregnancy
- •Absence of pregnancy before starting the embryo transfer cycle
- •Has given prior written consent
排除标准
- •- Important systemic diseases, endocrine-metabolic abnormalities involving the pituitary, thyroid, adrenals, pancreas, liver or kidney.
- •HIV, HBV or HCV seropositivity
- •Undiagnosed vaginal bleeding
- •Pregnancy, breastfeeding or any contraindication to becoming pregnant
- •Malformation of sexual organs incompatible with pregnancy
- •Known allergy to progesterone preparations or their excipients
- •Current dependence on alcohol, drugs or psychotropic medication
- •Concurrent participation in another study
- •Concomitant medication that could interfere with the study medication: different hormonal treatments used in the study, except thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with prostaglandin inhibitors
研究组 & 干预措施
Prolutex
Subcutaneous progesterone
干预措施: subcutaneous progesterone (Drug)
Progeffik
Vaginal progesterone
干预措施: vaginal progesterone (Drug)
结局指标
主要结局
ongoing pregnancy rate at 12 weeks gestation
时间窗: 12 weeks
ongoing pregnancy rate at 12 weeks gestation using subcutaneous progesterone and using vaginal progesterone capsules
次要结局
- progesterone level on the days of the transfer(5 days)
- progesterone level on biochemical pregnancy test beta-hCG(14 days)
- endometrium thickness on the day of oocyte retrieval(0 day)
- comfort in relation to the progesterone administration route(10 weeks)
- endometrium thickness on the day of embryo transfer(5 days)
- endometrium morphology on the day of oocyte retrieval(0 day)
- endometrium morphology on the day of embryo transfer(5 days)
- implantation rate(4-5 weeks)
- positive biochemical pregnancy test beta- hCG rate(14 days)
- clinical pregnancy rate(4-5 weeks)
- miscarriage rate(10 weeks)
- occurrence of side effects(day 5, day 14, 4-5 days, 10 weeks)
研究者
Joaquín Llácer
Gynaecologist. Reproductive Medicine Specialist at Instituto Bernabeu
Instituto Bernabeu