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Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients

ConditionsAdenomyosisIVFFrozen Embryo Transfer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorMỹ Đức Hospital

About this trial

This randomized clinical trial aims to assess the comparative effectiveness of two distinct endometrial preparation protocols for frozen embryo transfer (FET) among women with adenomyosis undergoing IVF/ICSI. Specifically, it seeks to address the following key questions:

1. Does the protocol involving the combination of GnRH agonist and letrozole for down regulation with exogenous steroids (GnRHa+AI - AC) result in a higher live birth rate compared to the use of exogenous steroids alone (AC) in women with adenomyosis undergoing frozen embryo transfer? 2. What are the common side effects of the GnRHa+AI - AC regimen?

Eligible participants will undergo screening before endometrial preparation for FET, following which they will be randomly assigned to one of two groups: GnRHa+AI - AC or AC. In the GnRHa+AI - AC group, participants will be pre-treated with GnRH agonist and letrozole two months before endometrial preparation. After this period, participants will return for endometrial preparation, and any side effects resulting from the down regulation will be evaluated. In contrast, the AC group will receive standard treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirm diagnosis with adenomyosis by using transvaginal ultrasonography (MUSA consensus) and/or pelvic magnetic resonance imaging.

Age between 18 - 42

Undergo less or equal to three previous IVF cycles

Indicate for frozen embryo transfer

Disqualifiers

Embryos from IVM cycle

Having uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal leiomyoma, or leiomyoma with endometrial cavity distortion)

Having contraindications for exogenous hormones administration: breast cancer, risks of venous thromboembolism

Embryos from the oocyte donation cycle.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GnRHa+AI - AC

    Procedure/Surgery

    Pre-treatment includes two doses of 3.75 mg GnRH agonist (Diphereline®, Ipsen, France) on days 2-4 of the menstrual cycle and 28 days later, along with daily 2.5 mg Letrozole (Femara®, Novartis, Switzerland) starting from the first agonist injection. Endometrial preparation in an artificial cycle begins 28 days after the second agonist injection. Patients take 6 mg/day of oral estradiol valerate (Valiera; Abbott) at least 9 days before progesterone. Endometrial thickness is monitored starting on the 10th day. When it reaches ≥7 mm, 400 mg twice times a day of vaginal progesterone (Cyclogest®, Actavis, UK) is initiated. Embryo transfer aligns with progesterone initiation, taking the embryo's stage into account. Luteal phase support comprises oral estradiol valerate 4 mg/day and vaginal progesterone 400 mg twice times a day until the 7th week of gestational age (GA), followed by progesterone alone at 400 mg twice times a day up to the 12th week of GA.

  • Artificial cycle

    Procedure/Surgery

    The endometrium will be prepared using oral estradiol valerate (Valiera; Abbott) 6 mg/day starting from the 2nd to the 4th day of the menstrual cycle. The endometrial thickness will be monitored from day 10th onwards, and vaginal progesterone (Cyclogest®; Actavis) 400 mg twice times a day will be initiated when endometrial thickness reaches ≥7 mm. Estradiol exposure must last for at least 9 days before progesterone administration. Embryo transfer will be scheduled by the time of the initiation of progesterone and embryo stages. Luteal phase support comprises estradiol 4 mg/day and vaginal progesterone 400 mg twice times a day until the 7th week of gestational age (GA), followed by progesterone alone at 400 mg twice times a day up to the 12th week of GA.

Treatment groups

222 Participants
are divided into 2 treatment groups
Group A: GnRH agonist + Letrzole - Artificial CycleActive comparator 1 intervention
Group B: Artificial CycleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Live birth rate after one frozen embryo transfer cycle

Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown

Time frame
At 22 weeks of gestation

Secondary outcomes

1

Cancellation rate

Cancellation due to: thin endometrium (thickness \<7mm after ≥21 days using oral estradiol valerate), endometrial cavity fluid, functional cyst (homogeneous anechoic cyst with d ≥14 mm present after 10 days using estradiol valerate), or has side effects(Cluster headache, mood swing, abnormal uterine bleeding, nausea, vomit, VTE, stroke)

Time frame
At 3 weeks from the start of artificial cycle
2

Hypoestrogenic side effects

Side effects include hot flushes, bone loss, vaginal dryness, decreased libido, unpredictable mood changes, and headache.

Time frame
At 8 weeks from the start of the first dose of 3.75 mg GnRH agonist
3

Classification of adenomyosis

The classification of adenomyosis under ultrasound scan according to MUSA criteria

Time frame
during ultrasound procedure
4

Differentiation of adenomyosis

The differentiation of adenomyosis under ultrasound scan according to MUSA criteria

Time frame
during ultrasound procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mỹ Đức Hospital

Lead sponsor

Source ClinicalTrials.gov
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