Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone: Prospective Randomized Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
Background:
The capability to transfer frozen embryos reduces embryo loss following in vitro fertilization (IVF) and results in higher pregnancy rates compared to a single IVF cycle.
Endogenous progesterone from the corpus luteum, following frozen embryo transfer in natural or modified natural cycles, is expected to provide sufficient luteal support, as observed in spontaneous pregnancies. Nevertheless, research has demonstrated higher pregnancy success rates with additional luteal support. The current standard for luteal phase support involves vaginal progesterone administration.
Several case reports have indicated that administering a gonadotropin-releasing hormone (GnRH) agonist during the luteal phase does not compromise pregnancy continuation achieved through IVF and may, in fact, enhance implantation success.
Studies have shown that the luteal phase can be maintained with a GnRH agonist alone, without the need for progesterone supplementation.
A recent prospective randomized controlled trial compared standard progesterone support with GnRH agonist support in fresh embryo transfers. The group receiving GnRH agonist support demonstrated a significantly higher pregnancy rate.
Given the studies proving the positive impact of GnRH agonist, there is a need for a prospective randomized controlled trial to evaluate the use of GnRH agonist support in frozen embryo transfers.
Aims and Significance:
This study aims to compare pregnancy rates between women receiving GnRH agonist treatment and those receiving standard progesterone-based luteal support during frozen embryo transfers in natural cycles as part of IVF treatments.
Conducting a prospective comparative study will enable us to assess the effectiveness of GnRH agonist treatment relative to standard luteal phase support. Based on the results, the investigators may consider treatment with intranasal GnRH agonist, which improves quality of life and may also enhance pregnancy and live birth rates.
Methods:
The study will be conducted on patients scheduled to undergo modified natural cycles. Participants will be randomly allocated into two groups:
- Study Group: Luteal phase support will begin on the day of ovulation with Nafarelin nasal spray (200 mcg twice daily) for two weeks, until pregnancy blood test (hCG).
- Control Group: Luteal phase support will be provided through vaginal progesterone. Endometrin 100 mg twice daily. If the hCG test is positive, the supportive treatment will continue until the 8th week of pregnancy, as per the attending physician's instructions.
Clinical follow-up will include monitoring for clinical pregnancy outcomes, miscarriage rates, and live births.
详细描述
Background:
The ability to transfer frozen embryos allows for the storage of embryos created during in vitro fertilization (IVF) treatments for later use. Frozen embryo transfers offer several advantages, such as reducing embryo loss following IVF and achieving higher pregnancy rates compared to a single IVF cycle. The rate of frozen embryo transfers has increased in recent years due to the growing trend of single embryo transfer (SET) in young women, the use of preimplantation genetic testing (PGT), and the prevention of ovarian hyperstimulation syndrome (OHSS). With recent advances in cryopreservation technology, embryo freezing offers the aforementioned benefits without compromising pregnancy rates.
There are several methods for preparing the endometrium for frozen embryo transfer:
- Natural Cycle (NC) - Timing ovulation by detecting the LH surge. The advantage of the natural cycle is the body's natural preparation for implantation without the need for medical intervention. However, its disadvantages include the need for close monitoring to detect ovulation and the inflexibility of embryo transfer timing, leading to a higher rate of cycle cancellations.
- Modified Natural Cycle (mNC) - Inducing ovulation using an hCG trigger injection. This method provides slightly greater flexibility in scheduling the embryo transfer according to clinical availability, reducing patient visits and improving convenience.
- Medicated Cycle - Preparing the endometrium with exogenous estrogen and progesterone. This method is suitable for women with irregular ovulation, offering greater flexibility and fewer cycle cancellations.
Studies comparing natural and modified natural cycles have yielded inconclusive results.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women treated at the Shaare Zedek IVF clinic scheduled for frozen embryo transfer
- •Normo-ovulatory women
- •Women undergoing frozen embryo transfer in a modified natural cycle
排除标准
- •Women undergoing medicated FET cycles
- •BMI >35 or <18
- •Women with hydrosalpinx
- •Women with congenital or acquired uterine anomalies (e.g., myomas)
- •Egg donation or surrogacy
- •Women with endometriosis
- •Intolerance to GnRH agonists
- •Nasal congestion or respiratory conditions affecting nasal absorption
研究组 & 干预措施
SYNAREL
LUTEAL PHASE SUPPORT WITH SYNAREL 200 MCG X2 DAY
干预措施: Nafarelin nasal spray (Drug)
UTEROGESTAN
LUTEAL PHASE SUPPORT WITH UTEROGESTAN 200 MG X2 DAY
干预措施: Utrogestan® (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: two months after ET
positive fetal heart beat
次要结局
- positive pregancny(two weeks after ET)
- implantation rate(two months after ET)
- live birth rate(9 months after the treatment)
- miscarriage rate(up to 24 weeks pregnancy)
研究者
Yael Lerner
MD
Shaare Zedek Medical Center