| CTRI Number |
CTRI/2025/04/084444 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing natural and artificial frozen embryo transfer in ovulating women |
|
Scientific Title of Study
|
To compare the effect of endometrial preparation using natural cycle versus hormone replacement cycle on frozen embryo transfer outcomes in ovulatory infertile women :
A randomised controlled trial
|
| 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 REKHA R |
| Designation |
senior resident MCh in Reproductive medicine |
| Affiliation |
AIIMS New Delhi |
| Address |
Assisted Reproductive Technology centre, Service floor,Department of obstetrics and gynaecology, Mother and child block,AIIMS,New Delhi
South
DELHI
110029
India |
| Phone |
9731840667 |
| Fax |
|
| Email |
drrekhajiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEETA SINGH |
| Designation |
Professor in OBG |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of obstetrics and gynaecology, 7th floor, Mother and child block,
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9818506855 |
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR REKHA R |
| Designation |
Senior resident in MCh in reproductive medicine |
| Affiliation |
AIIMS New Delhi |
| Address |
ART division,Service floor, Department of obstetrics and gynaecology, Mother and child block,
AIIMS,NEW DELHI
South
DELHI
110029
India |
| Phone |
9731840667 |
| Fax |
|
| Email |
drrekhajiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
ANSARI NAGAR NEW DELHI |
| Type of Sponsor |
Government 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 REKHA R |
All India Institute of medical sciences,New Delhi |
ART division,service floor, Department of OBG, Mother and child block, AIIMS, New Delhi
South
DELHI |
9731840667
drrekhajiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O090||Supervision of pregnancy with history of infertility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hormone replacement FET cycle |
Patient will receive oral estradiol valerate 2 mg three times a day starting on day2 or 3 of menstrual cycle after a basal transvaginal ultrasound and blood test for hormones and on from day8 onwards,the endometrial thickness will be monitored by vaginal ultrasonography.Estradiol upto12mg and estrabet gel 2 puffs bd for local application will be added if endometrial growth is not adequate. If the endometrial thickness reaches 7mm and above estrogen will be continued and Inj progesterone 100 mg per day will be given intramuscularly for 6 days for day 5 FET. |
| Intervention |
NATURAL CYCLE FET |
On day2 OR 3 of menstrual cycle after a basal transvaginal ultrasound and blood test for hormones and then monitored serially from day8 onwards till the time of ovulation. Blood test for hormones to confirm ovulation will be done. From the day of ovulation and endometrial thickness reaches 7 mm and above patient will receive Inj progesterone 100 mg per day intramuscularly for 6 days for day 5FET |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Infertile women awaiting day 5 (blastocyst) frozen embryo transfer with Regular menstrual cycles (24 to 38 days) with a variation of ±3 days |
|
| ExclusionCriteria |
| Details |
Anovulatory women
Contraindications for hormones
Presence of hydrosalpinx
Uterine abnormalities Mullerian anomalies
fibroid
adenomyosis
endometrial polyp
intrauterine adhesions
Chronic systemic diseases
PCOS
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical pregnancy rate |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ongoing pregnancy rate
Early miscarriage rate
Ectopic pregnancy rate
Cycle cancellation rate
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drrekhajiya@gmail.com].
- For how long will this data be available start date provided 30-03-2025 and end date provided 31-12-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - drrekhajiya@gmail.com
|
Brief Summary
Modification(s)
|
This study is a randomized controlled trial comparing the effectiveness and safety of natural cycle frozen embryo transfer versus hormone replacement cycle FET in ovulatory infertile women Conducted at the ART Centre,Department of Obstetrics & Gynecology AIIMS New Delhi from ethical clearance to July 2026 the study will include 60 women aged 21 to 40 years with regular menstrual cycles undergoing day 5 blastocyst transfer Exclusion criteria include anovulation systemic diseases PCOS and uterine abnormalities Participants will be randomized into two groups NC-FET where ovulation is monitored through serial transvaginal ultrasound and hormonal assessment before progesterone supplementation and embryo transfer and HRC FET where estradiol valerate is used for endometrial preparationfollowed by progesterone supplementation and embryo transfer The primary objective is to compare clinical pregnancy rates while secondary outcomes include ongoing pregnancy rate early miscarriage rate ectopic pregnancy rate and cycle cancellation rate Statistical analysis will use descriptive and inferential tests with significance set at p less than 0.05 This study aims to provide robust evidence to guide the selection of the optimal FET protocol in ovulatory infertile women |