Health TrialsbyHealthPanel

FET in Adenomyosis

ConditionAdenomyosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-42
SponsorIndira IVF Hospital Pvt Ltd

About this trial

Purpose of the Study:

To compare the effectiveness of GnRH agonist downregulation alone versus GnRH agonist combined with letrozole in improving pregnancy outcomes in women with adenomyosis undergoing frozen embryo transfer (FET).

Research Question:

Is the combined use of GnRH agonist and letrozole more effective than GnRH agonist downregulation alone in achieving better ongoing pregnancy rates in adenomyosis cases undergoing FET?

Hypothesis:

Null Hypothesis (H₀): The combined use of GnRH agonist and letrozole is not more effective than GnRH agonist downregulation alone in achieving a higher ongoing pregnancy rate in adenomyosis cases undergoing FET.

Study Outcomes:

Primary Outcome: Ongoing pregnancy rate at 12 weeks of gestation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • GnRH agonist downregulation

    Drug

    Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval

  • GnRH agonist and Letrozole

    Drug

    Triptorelin Acetate 3.75mg for two consecutive dosages at 30 days interval) + Letrozole (5 mg once daily for a total of 21 days during the second depot - letrozole stops when Estrogen priming starts

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ongoing pregnancy rate

Presence of gestational sacs with a heartbeat at the 12th gestational week. The ongoing pregnancy rate will be calculated using the below formula. Ongoing pregnancy rate: (the number of ongoing pregnancy cases/the number of clinical pregnancy cases) × 100%

Time frame
12 weeks of gestation

Secondary outcomes

1

Implantation Rate

The number of gestational sacs observed by transvaginal ultrasound at the 6th gestational week per the number of embryos transferred. The implantation rate will be calculated using the below formula. Implantation rate: (The number of gestational sacs observed/ number of embryos transferred) × 100

Time frame
4 weeks after embryo transfer
2

Chemical Pregnancy rate

Detection of a fetal heartbeat on transvaginal ultrasound at the 6th gestational week. The clinical pregnancy rate will be calculated using the below formula.

Time frame
4 weeks after embryo transfer
3

Biochemical loss rate

Pregnancies diagnosed only by β-human chorionic gonadotropin detection without a gestational sac visualized by vaginal ultrasound at the 6th gestational week. The biochemical loss rate will be calculated using the below formula. Biochemical loss rate: (the number of biochemical pregnancy loss cases/the number of women per group) × 100%

Time frame
4 weeks after embryo transfer
4

1st trimester loss

First-trimester loss refers to the spontaneous loss of a pregnancy occurring before the end of the 12th week of gestation

Time frame
12 weeks of gestation

Other outcomes

Sponsors and contacts

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

Indira IVF Hospital Pvt Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: