AdenomyosisADYNCT06913075
FET in Adenomyosis
A study testing GnRH agonist downregulation and GnRH agonist and Letrozole in people with Adenomyosis, run by Indira IVF Hospital Pvt Ltd at 1 site in India.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 to 42 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- GnRH agonist downregulation and GnRH agonist and Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jun 2026to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of adenomyosis confirmed via transvaginal ultrasound as per MUSA criteria History of infertility requiring frozen embryo transfer (FET). Availability of at least one good-quality frozen embryo for transfer
Who cannot join
- BMI ≥ 30 kg/m2 Presence of endocrine disorders; (uncontrolled diabetes mellitus, / hyperprolactinemia, thyroid dysfunction, Congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome Previous major uterine surgery Gestational carrier Fertility preservation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Indira IVF Pvt Hospital
Udaipur, Rajasthan, 313001
Vipin Chandra, DGO, drvipinchandra@indiraivf.in
Taruna Jhamb, MD
About this study
Official title: Is GnRH Agonist Plus Letrozole a Better Choice Than GnRH Agonist Alone in Adenomyosis Cases Undergoing Frozen Embryo Transfer?
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).
Read more
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.
- Conditions
- Adenomyosis
- Being tested
- GnRH agonist downregulation, GnRH agonist and Letrozole
- Keywords
- Frozen embryo transfer, Adenomyosis, ongoing pregnancy rate, live birth rate
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonist downregulationDrug
Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval
GnRH agonist and LetrozoleDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: Drug: GnRH agonist downregulation |
| Group B | Active comparator | Not described Receives: Drug: GnRH agonist and Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 12 weeks of gestation
Secondary outcomes (6)
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
Measured: 4 weeks after embryo transfer
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.
Measured: 4 weeks after embryo transfer
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%
Measured: 4 weeks after embryo transfer
1st trimester loss
First-trimester loss refers to the spontaneous loss of a pregnancy occurring before the end of the 12th week of gestation
Measured: 12 weeks of gestation
2nd trimester loss
Second-trimester loss refers to the spontaneous loss of a pregnancy occurring between 13 and 20 weeks of gestation.
Measured: 20 weeks of gestation
Live Birth Rate
The number of deliveries that resulted in at least one live birth per 100 Embryo transferred cycle.
Live birth rate: (The number of live births / the number of embryos transferred cycle) × 100
Measured: Post delivery after completion of 20 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start25 Jun 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indira IVF Hospital Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913075
- Sponsor's protocol ID
- IIHL/UDR/P/003_2024
- Acronym
- ADY
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: he Individual Participant Data (IPD) will be shared with authorized researchers upon request. The supporting documents, including the study protocol, SAP, and ICF, will be provided alongside the IPD to ensure comprehensive understanding and proper data interpretation. When: IPD will be available after the completion of the study and publication of primary results. How: IPD will be shared through a secure data repository or via encrypted files sent through secure email upon request, following proper data use agreements.
Publications
Salim R, Riris S, Saab W, Abramov B, Khadum I, Serhal P. Adenomyosis reduces pregnancy rates in infertile women undergoing IVF. Reprod Biomed Online. 2012 Sep;25(3):273-7. doi: 10.1016/j.rbmo.2012.05.003. Epub 2012 May 23.
PubMed 22832421Younes G, Tulandi T. Effects of adenomyosis on in vitro fertilization treatment outcomes: a meta-analysis. Fertil Steril. 2017 Sep;108(3):483-490.e3. doi: 10.1016/j.fertnstert.2017.06.025.
PubMed 28865548Han B, Liang T, Zhang W, Ma C, Qiao J. The effect of adenomyosis types on clinical outcomes of IVF embryo transfer after ultra-long GnRH agonist protocol. Reprod Biomed Online. 2023 Feb;46(2):346-351. doi: 10.1016/j.rbmo.2022.09.021. Epub 2022 Sep 26.
PubMed 36549997Sharma S, RoyChoudhury S, Bhattacharya MP, Hazra S, Majhi AK, Oswal KC, Chattopadhyay R. Low-dose letrozole - an effective option for women with symptomatic adenomyosis awaiting IVF: a pilot randomized controlled trial. Reprod Biomed Online. 2023 Jul;47(1):84-93. doi: 10.1016/j.rbmo.2023.03.010. Epub 2023 Mar 18.
PubMed 37149412Li Y, Ge L, Yang X, Cui L, Chen ZJ. Effects of duration of long-acting GnRH agonist downregulation on assisted reproductive technology outcomes in patients with adenomyosis: a retrospective cohort study. Front Med (Lausanne). 2023 Sep 26;10:1248274. doi: 10.3389/fmed.2023.1248274. eCollection 2023.
PubMed 37822471
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is GnRH Agonist Plus Letrozole a Better Choice Than GnRH Agonist Alone in Adenomyosis Cases Undergoing Frozen Embryo Transfer?
- ClinicalTrials.gov ID
- NCT06913075
- Acronym / sponsor ID
- ADY / IIHL/UDR/P/003_2024
- Conditions
- Adenomyosis
- Keywords
- Frozen embryo transfer, Adenomyosis, ongoing pregnancy rate, live birth rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Indira IVF Hospital Pvt LtdUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: GnRH agonist downregulation |
| Group B | Active comparator | Drug: GnRH agonist and Letrozole |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of adenomyosis confirmed via transvaginal ultrasound as per MUSA criteria History of infertility requiring frozen embryo transfer (FET). Availability of at least one good-quality frozen embryo for transfer
Key exclusion criteria (1 listed)
- BMI ≥ 30 kg/m2 Presence of endocrine disorders; (uncontrolled diabetes mellitus, / hyperprolactinemia, thyroid dysfunction, Congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome Previous major uterine surgery Gestational carrier Fertility preservation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnRH agonist downregulationTriptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval | Drug | Group A |
| GnRH agonist and LetrozoleTriptorelin 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 | Drug | Group B |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks of gestation
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%
6 secondary outcomes
Implantation Rate
Time frame: 4 weeks after embryo transfer
Chemical Pregnancy rate
Time frame: 4 weeks after embryo transfer
Biochemical loss rate
Time frame: 4 weeks after embryo transfer
1st trimester loss
Time frame: 12 weeks of gestation
2nd trimester loss
Time frame: 20 weeks of gestation
Live Birth Rate
Time frame: Post delivery after completion of 20 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Results publication: PubMed 22832421Salim R, Riris S, Saab W, Abramov B, Khadum I, Serhal P. Adenomyosis reduces pregnancy rates in infertile women undergoing IVF. Reprod Biomed Online. 2012 Sep;25(3):273-7. doi: 10.1016/j.rbmo.2012.05.003. Epub 2012 May 23.
- Results publication: PubMed 28865548Younes G, Tulandi T. Effects of adenomyosis on in vitro fertilization treatment outcomes: a meta-analysis. Fertil Steril. 2017 Sep;108(3):483-490.e3. doi: 10.1016/j.fertnstert.2017.06.025.
- Results publication: PubMed 36549997Han B, Liang T, Zhang W, Ma C, Qiao J. The effect of adenomyosis types on clinical outcomes of IVF embryo transfer after ultra-long GnRH agonist protocol. Reprod Biomed Online. 2023 Feb;46(2):346-351. doi: 10.1016/j.rbmo.2022.09.021. Epub 2022 Sep 26.
- Results publication: PubMed 37149412Sharma S, RoyChoudhury S, Bhattacharya MP, Hazra S, Majhi AK, Oswal KC, Chattopadhyay R. Low-dose letrozole - an effective option for women with symptomatic adenomyosis awaiting IVF: a pilot randomized controlled trial. Reprod Biomed Online. 2023 Jul;47(1):84-93. doi: 10.1016/j.rbmo.2023.03.010. Epub 2023 Mar 18.
- Results publication: PubMed 37822471Li Y, Ge L, Yang X, Cui L, Chen ZJ. Effects of duration of long-acting GnRH agonist downregulation on assisted reproductive technology outcomes in patients with adenomyosis: a retrospective cohort study. Front Med (Lausanne). 2023 Sep 26;10:1248274. doi: 10.3389/fmed.2023.1248274. eCollection 2023.
- Individual participant dataSharing planned: Yes. he Individual Participant Data (IPD) will be shared with authorized researchers upon request. The supporting documents, including the study protocol, SAP, and ICF, will be provided alongside the IPD to ensure comprehensive understanding and proper data interpretation. When: IPD will be available after the completion of the study and publication of primary results. How: IPD will be shared through a secure data repository or via encrypted files sent through secure email upon request, following proper data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRH agonist downregulation and GnRH agonist and Letrozole in people with Adenomyosis, run by Indira IVF Hospital Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taruna Jhamb, MD (+91 9799035674, centerhead.udaipur@indiraivf.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06913075, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.