Natural vs Programmed Frozen Embryo Transfer for Pregnancy (NatPro Trial)
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: JHSPH Center for Clinical Trials
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).
What safety data exists for natural vs programmed frozen embryo transfer treatments?The safety data for natural vs programmed frozen embryo transfer treatments includes studies on obstetric and neonatal risks, as well as obstetric complications and perinatal outcomes. One study suggests increased obstetric and neonatal risks in artificial cycles compared to modified natural cycles. Another study evaluates obstetric complications and perinatal outcomes in natural cycle (NC-FET) versus hormone therapy cycle (HT-FET), focusing on serum estradiol and progesterone levels. Additionally, there is concern about increased maternal and perinatal morbidity in hormone therapy protocols due to the lack of corpus luteum. Overall, these studies provide insights into the safety and risks associated with different frozen embryo transfer protocols.25689
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, you can continue using thyroid medication if needed. If you have a rheumatologic disease requiring chronic systemic medications, you cannot participate in the trial.
What data supports the idea that Natural vs Programmed Frozen Embryo Transfer for Pregnancy is an effective treatment?The available research shows that both natural cycle (NC) and hormone therapy (HT) frozen embryo transfers are effective treatments. Some studies suggest that NC might be as good as or even better than HT for patients with regular cycles. This is because NC uses the body's natural hormones, which might lead to better outcomes. However, the research is still ongoing to determine which method is more effective overall. Both methods are simpler and less costly compared to other treatments like repeated fresh embryo transfers.23458
Is the treatment Modified natural cycle, Programmed cycle a promising treatment for pregnancy?The Modified natural cycle and Programmed cycle treatments are promising for pregnancy because they are effective in preparing the body for frozen embryo transfer, with some studies suggesting a higher chance of pregnancy with the natural cycle.12578
Eligibility Criteria
Women aged 18-41 with at least one high-quality or genetically tested blastocyst for IVF, a normal uterine cavity, regular ovulatory cycles, and a BMI <=40. They must be willing to undergo single embryo transfer and randomization to either modified natural or programmed cycle FET. Exclusions include use of donor oocytes, uncontrolled diabetes or hypertension, certain uterine anomalies, and systemic rheumatologic diseases.Inclusion Criteria
I have at least one healthy embryo frozen for future use.
Exclusion Criteria
I have a uterine condition that cannot be fixed with surgery.
My high blood pressure is not under control.
I have an untreated hydrosalpinx.
I have a condition that affects my immune system and requires ongoing medication.
My diabetes is not well-controlled.
I am not allergic or unable to take medications needed for embryo transfer.
Participant Groups
The NatPro trial is testing two different methods for frozen embryo transfer in IVF: the 'modified natural cycle' which works with the body's own hormones (corpus luteum present), versus the 'programmed cycle' where specific hormones are administered (corpus luteum absent). Women will be randomly assigned to one of these two approaches.
2Treatment groups
Active Control
Group I: Programmed cycleActive Control1 Intervention
corpus luteum absent
Group II: Modified natural cycleActive Control1 Intervention
corpus luteum present
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
West Virginia University Center for Reproductive MedicineMorgantown, WV
University of California San FranciscoSan Francisco, CA
Northwestern UniversityChicago, IL
Johns HopkinsBaltimore, MD
More Trial Locations
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Who is running the clinical trial?
JHSPH Center for Clinical TrialsLead Sponsor
References
The effect of cycle regimen used for endometrium preparation on the outcome of day 3 frozen embryo transfer cycle. [2022]Three cycle regimens to prepare the patients' endometrium for day 3 frozen embryo transfer cycle have been evaluated (natural cycle, hormonally manipulated artificial programmed, and stimulated cycles). All three procedures were equally effective in terms of pregnancy outcome, although a higher probability of pregnancy was found in the natural cycle.
Frozen-thawed embryo transfers in natural cycles with spontaneous or induced ovulation: the search for the best protocol continues. [2018]Is natural cycle frozen-thawed embryo transfer (NC-FET) associated with better clinical pregnancy rates (CPR) when compared to modified natural cycle frozen-thawed embryo transfer (mNC-FET)?
Impact of Endometrial Preparation Protocols for Frozen Embryo Transfer on Live Birth Rates. [2020]It has been reported that a natural cycle (NC) is similar to or even better than hormone replacement therapy (HRT) in patients with regular cycles who undergo frozen embryo transfer (FET). Hundreds of FETs are managed yearly in our clinic. Scheduling these cycles is critical in a busy unit like ours. This is why we have to prove if a NC really shows a better outcome than other endometrium preparation protocols.
Cycle regimens for frozen-thawed embryo transfer. [2023]Among subfertile couples undergoing assisted reproductive technology (ART), pregnancy rates following frozen-thawed embryo transfer (FET) treatment cycles have historically been found to be lower than following embryo transfer undertaken two to five days following oocyte retrieval. Nevertheless, FET increases the cumulative pregnancy rate, reduces cost, is relatively simple to undertake and can be accomplished in a shorter time period than repeated in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles with fresh embryo transfer. FET is performed using different cycle regimens: spontaneous ovulatory (natural) cycles; cycles in which the endometrium is artificially prepared by oestrogen and progesterone hormones, commonly known as hormone therapy (HT) FET cycles; and cycles in which ovulation is induced by drugs (ovulation induction FET cycles). HT can be used with or without a gonadotrophin releasing hormone agonist (GnRHa). This is an update of a Cochrane review; the first version was published in 2008.
Modified natural-cycle cryopreserved embryo transfer: is a washout period needed after a failed fresh cycle? [2020]Are the characteristics of the natural cycle or modified natural cycle (mNC), or live birth rates (LBR), affected by delaying frozen embryo transfer (FET) after a failed fresh IVF cycle?
Increased obstetric and neonatal risks in artificial cycles for frozen embryo transfers? [2021]What are the obstetric and neonatal risks for women conceiving via frozen-thawed embryo transfer (FET) during a modified natural cycle compared with an artificial cycle method.
Endometrial preparation methods prior to frozen embryo transfer: A retrospective cohort study comparing true natural cycle, modified natural cycle and artificial cycle. [2022]The aim of this study was to compare the outcomes of three endometrial preparation methods prior to frozen embryo transfer (FET): Natural cycle (NC), modified natural cycle (mNC), and programmed/artificial cycle (AC) protocols. Primary outcomes investigated were clinical pregnancy rate (CPR) and live birth rate (LBR).
Comparison of endometrial preparation protocols (natural cycle versus hormone replacement cycle) for frozen embryo transfer (COMPETE): a study protocol for a randomised controlled trial. [2022]Natural cycle (NC) and hormone replacement treatment (HT) are frequently used endometrial preparation protocols prior to frozen-thawed embryo transfer in ovulatory women. It is not clear which protocol results in a higher live birth rate. It has been suggested that there is an increased risk in maternal and perinatal morbidity following HT protocol due to the lack of corpus luteum. The objective of this trial is to compare the clinical outcomes of NC and HT protocols in frozen embryo transfer.
The impact of serum estradiol and progesterone levels during implantation on obstetrical complications and perinatal outcomes in frozen embryo transfer. [2023]This study sought to evaluate obstetric complications and perinatal outcomes in frozen embryo transfer (FET) using either a natural cycle (NC-FET) or a hormone therapy cycle (HT-FET). Furthermore, we investigated how serum levels of estradiol (E2) and progesterone (P4) on the day of and 3 days after embryo transfer (ET) correlated with clinical outcomes in the two groups.