| CTRI Number |
CTRI/2026/01/101261 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare pregnancy results in women undergoing frozen embryo transfer with or without hormone treatment |
|
Scientific Title of Study
|
Comparative evaluation of Reproductive Outcomes between Ovulatory
(Natural and modified Natural) cycle and Hormone-replacement therapy cycle for frozen-thawed
embryo transfers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Wavhal Sumedh Shashikant |
| Designation |
MCh Resident |
| Affiliation |
Kasturba Medical College and Hospital, MAHE, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, Kasturba Medical College and Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9967883775 |
| Fax |
|
| Email |
wavhal.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Adiga |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College and Hospital, MAHE, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, Kasturba Medical College and Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9035036832 |
| Fax |
|
| Email |
prashanth.adiga@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Adiga |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College and Hospital, MAHE, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, Kasturba Medical College and Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9035036832 |
| Fax |
|
| Email |
prashanth.adiga@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Udupi-Hebri road, Madhav Nagar, Manipal - 576104, Dist. Udupi, State - Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital, MAHE, Manipal |
| Address |
Udupi-Hebri Road, Madhav Nagar, Manipal - 576104, Dist. Udupi, Karnataka |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Wavhal Sumedh Shashikant |
Kasturba Medical College and Kasturba Hospital |
Department of Reproductive Medicine and Surgery, Kasturba Medical College and Hospital, Udupi-Hebri road, Madhav Nagar, Manipal - 576104, Dist Udupi
Udupi
KARNATAKA |
9967883775
wavhal.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women with regular cycles 21 to 35 days
More than 5 oocytes retrieved
FET using NC, modified NC or HRT protocol
Day 3 or Day 5 embryo transfer with Self oocytes (all cycles) and Donor oocytes (except 1st cycle)
Pre transfer Endometrial thickness more than or equal to 7 mm
|
|
| ExclusionCriteria |
| Details |
Müllerian anomalies, Uterine anomalies
Single ovary
PCOS or oligo or anovulation
Recurrent pregnancy losses
Stimulated cycles
Aneuploid embryos ,if PGT A was performed
Fresh transfers
Grade III cleavage stage and Grade C blastocyst transfers
Difficult embryo transfers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare Clinical Pregnancy rates |
2 weeks Beta hCG
6 weeks TVS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biochemical pregnancy rate |
2 weeks Beta hCG |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The accumulated evidence suggests that while reproductive outcomes such as implantation and live
birth may appear similar in earlier studies, recent high-quality RCTs and prospective cohorts show an
advantage of natural cycle approaches over HRT in ovulatory women. Importantly, obstetric outcomes
— particularly hypertensive disorders and placental complications — appear worse in programmed
cycles, plausibly due to the absence of corpus luteum. Indian data remain limited and largely
retrospective, highlighting a critical gap. A prospective observational study comparing NC and HRT
cycles in Indian eumenorrhoeic women, with systematic assessment of reproductive and obstetric
outcomes, will therefore provide valuable insights and help tailor ART practices to the local population. |