Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates
- Conditions
- Luteal Phase Support
- Interventions
- Registration Number
- NCT05838105
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief Summary
The aim of the study is to compare the pregnancy rate between women treated with Gonadotropin Releasing Hormone (GnRH) agonist together with Human Chorionic Gonadotropin (HCG) and standard luteal support with progesterone following transfer of frozen embryos in in-vitro-fertilization (IVF) natural cycles.
- Detailed Description
The rate of frozen embryos transfer (FET) has increased in recent years due to a higher tendency of single embryo transfer, use of preimplantation genetic testing, and prevention of ovarian hyperstimulation.
There are different methods to prepare the endometrium for FET:
1. Natural cycle (NC) - natural preparation of the body for implantation without the need for medicinal intervention.
2. Modified natural cycle (mNC) - Inducing ovulation by administration of Human Chorionic Gonadotropin (HCG) trigger.
3. Medical - preparation of endometrium with hormones (estrogen and progesterone).
Following embryo transfer, luteal phase support should be considered. Administration of treatment depends on the type of cycle chosen (either natural or medicated). Treatment options include progesterone, HCG and Gonadotropin Releasing Hormone (GnRH) analog - either one of them or combined. Different protocols (dosages and duration of use) with different pregnancy outcomes were explore before with inconclusive results. We wish to investigate administration of GnRH agonist+HCG vs. progesterone.
Patients included in the study will be women undergoing natural cycle FET at the IVF center in Shaare Zedek, Jerusalem, Israel. All patients will be randomly divided into two groups, each will receive a different luteal treatment support as will be detailed later. Patients demographic data and pregnancy outcomes will be collected.
Based on the clinical pregnancy rate in the prospective study by Bjuresten, et al \[Fertil Steril, 2011\], where a clinical pregnancy rate of 32% was found among women treated with progesterone for luteal support, and given an alpha of 5% and a power of 80%, 144 women (72 women in each group) are required in order to demonstrate a clinical pregnancy rate of 55% in the study group.
Comparison of categorical variables will be carried out using the the chi-squared test. Comparison of continuous variables will be performed using the Students t-Test or Mann-Whitney U method depending on the variable distribution (normal vs. non-normal distribution, respectively). A multivariate regression will also be conducted in order to determine which variables are significantly and independently related. Statistical significance will be defined when P values are less than 0.05
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 144
- Normo-ovulatory women
- Women undergoing frozen embryos transfer in a natural cycle
- Age 18-45
- BMI 18-35
- Women undergoing medicated frozen embryos transfer
- Women with a BMI over 35 or under 18.
- Women with hydrosalpinges
- Women with defects or uterine malformations (congenital) or acquired such as myomas
- Egg donation and surrogacy
- Use of preimplantation genetic testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Progesterone 100Mg Vag Tab Patients will receive luteal support with vaginal progesterone - 100 mg Endometrin twice daily until week 8 of pregnancy. Study group GnRH agonist Patients will receive luteal support with GNRH agonist and HCG according to departmental protocol: Cleavage stage embryo: * ET day (embryo day 2-3) - Ovitrelle 125mcg * Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg * Day 6 after ET- Ovitrelle 125mcg * Day 9 after ET - Ovitrelle 125mcg Embryo blastocyst stage: * ET day (embryo day 5-6) - Ovitrelle 125mcg + Decapeptyl 0.1mg * Day 3 after ET - Ovitrelle 125mcg * Day 6 after ET - Ovitrelle 125mcg Study group hCG Patients will receive luteal support with GNRH agonist and HCG according to departmental protocol: Cleavage stage embryo: * ET day (embryo day 2-3) - Ovitrelle 125mcg * Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg * Day 6 after ET- Ovitrelle 125mcg * Day 9 after ET - Ovitrelle 125mcg Embryo blastocyst stage: * ET day (embryo day 5-6) - Ovitrelle 125mcg + Decapeptyl 0.1mg * Day 3 after ET - Ovitrelle 125mcg * Day 6 after ET - Ovitrelle 125mcg
- Primary Outcome Measures
Name Time Method Clinical pregnancy rate up to two month after embryo transfer visualization of intrauterine gestational sac on ultrasound divided by number of transfers
- Secondary Outcome Measures
Name Time Method Overall pregnancy rate up to two month after embryo transfer number positive beta-hCG divided by total number of transfers
Live birth rate up to 42 weeks after embryo transfer number of live births after 24 weeks divided by number of transfers.
Implantation rate up to two month after embryo transfer number of gestational sacs divided by number of embryos transferred
Ectopic pregnancy rate up to two month after embryo transfer number of ectopic pregnancy divided by number of positive beta-hCG
Miscarriage rate up to 20 weeks after embryo transfer number of non-viable before 24 weeks divided by total number of positive beta-hCG
Trial Locations
- Locations (1)
Shaare Zedek medical center
🇮🇱Jerusalem, Israel