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CTRI Number  CTRI/2025/04/084166 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effectiveness of two treatments—clomiphene citrate and ultra-short flare agonist—for women with low egg count undergoing fertility treatment. 
Scientific Title of Study   To assess the efficacy of clomiphene citrate flare effect in the flexible antagonist protocol versus ultra short flare agonist protocol in diminished ovarian reserve.  
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 Parinaaz Parhar 
Designation  Consultant 
Affiliation  Oasis Fertility, Secunderabad: OSHERM 
Address  Department of Academics, Room no 1- Reproductive Medicine Division, , 2nd Floor, CVK Park Square, Krishna Complex, Oxford Street, Sarojini Devi Road, Kalasiguda, Secunderabad.
Oasis School of Human Embryology and Reproductive Medicine, Department of Reproductive Medicine, Door No:8-2-120/112/a/7, Road No 9, Jubilee Hills, Park View Enclave, Hyderabad, Telangana-500033.
Hyderabad
TELANGANA
500003
India 
Phone  9881474476  
Fax  07825850105  
Email  parinaaz.parhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parinaaz Parhar 
Designation  Consultant 
Affiliation  Oasis Fertility, Secunderabad ; OSHERM 
Address  Department of Academics, Room no 1- Reproductive Medicine Division, , 2nd Floor, CVK Park Square, Krishna Complex, Oxford Street, Sarojini Devi Road, Kalasiguda, Secunderabad.
OSHERM, Department of Reproductive Medicine, Door No:8-2-120/112/a/7, Road No 9, Jubilee Hills, Park View Enclave, Hyderabad, Telangana-500033.
Hyderabad
TELANGANA
500003
India 
Phone  9881474476  
Fax  07825850105  
Email  parinaaz.parhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parinaaz Parhar 
Designation  Consultant 
Affiliation  Oasis Fertility, Secunderabad 
Address  Oasis School of Human Embryology and Reproductive Medicine, Department of Reproductive Medicine, Door No:8-2-120/112/a/7, Road No 9, Jubilee Hills, Park View Enclave, Hyderabad, Telangana-500033.
Department of Academics, Room no 1- Reproductive Medicine Division, , 2nd Floor, CVK Park Square, Krishna Complex, Oxford Street, Sarojini Devi Road, Kalasiguda, Secunderabad- 500003
Hyderabad
TELANGANA
500033
India 
Phone  9881474476  
Fax  07825850105  
Email  parinaaz.parhar@gmail.com  
 
Source of Monetary or Material Support  
Self funded by the institute, Oasis Fertility. Address: Oxford Street, Sarojini Devi Road, 2nd Floor CVK Park Square, Krishna Complex, Kalasiguda, Secunderabad-500003, Telangana, India. 
 
Primary Sponsor  
Name  Oasis Fertility 
Address  Oxford Street, Sarojini Devi Road, 2nd Floor CVK Park Square, Krishna Complex, Kalasiguda, Secunderabad-500003 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirzarini Vora   Oasis Fertility  Department of Academics, Room no 1- Reproductive Medicine Division, , 2nd Floor, CVK Park Square, Krishna Complex, Oxford Street, Sarojini Devi Road, Kalasiguda, Secunderabad-500003
Hyderabad
TELANGANA 		 8866869658

nirzarini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Oasis Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infertile women in reproductive age group with diminished ovarian reserve 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  100 mg of Clomiphene citrate once daily for 5 days in a flexible GnRH antagonist protocol Group B - Ultrashort flare protocol  100 mg of Clomiphene citrate was administered once daily for 5 days along with 300-450IU of human menopausal gonadotropin starting from D1 or 2 of the menstrual cycle, after confirming ovarian downregulation, in a flexible Gn RH antagonist protocol where once the dominant follicle was more than 14 mm 0.25 mg of GnRH antagonist was started to prevent premature leutinization.  
Comparator Agent  Ultrashort flare protocol using 1mg of undiluted leuprolide once daily for 4 days  1mg of undiluted leuprolide once daily for 4 days was started with 300-450IU of human menopausal gonadotropin from day 1 or 2 of menses in a flexible GnRH antagonist protocol again using 0.25 mg of cetrotide daily till trigger injection to avoid premature leutinization and ovulation. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  42.00 Year(s)
Gender  Female 
Details  Infertile women with Anti mullerian hormone levels less than 1.2 ng/ml and antral follicle count less than 5 will be included. 
 
ExclusionCriteria 
Details  Those with severe endometriosis, adenomyosis, congenital uterine malformations and with male partners having severe Oligoasthenoteratozoospermia will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Mean total gonadotropin consumption
2.duration of stimulation
3. oocytes retrieval rate,
4. M2 rate and
5. fertilisation rate 		 Outcomes will be measured after 15 days from the start of the IVF cycle at the onset of menstrual cycle. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Follicular output rate (FORT) ,
2. Follicle to oocyte index (FOI) ,
3.top quality embryo rate , 4.cycle cancellation rate , 5.implantation rate & 6.clinical pregnancy rate 		 Outcomes will be measured after 15 days from the start of the IVF cycle at the onset of menstrual cycle. 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   10/04/2025 
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)
Modification(s)  		 Not Applicable 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [parinaaz.parhar@gmail.com].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   A randomized controlled trial to compare the outcomes of controlled ovarian stimulation in patients with diminished ovarian reserve(POSEIDON groups 3 &4) using Clomiphene citrate with flexible GnRH antagonist  vs ultrashort flare protocol. The patients in the 2 groups will be compared primarily  for their no of oocytes retrieved, maturation rate, fertilization rate, total dosage of gonadotropin dosage used , total duration of stimulation . Secondary outcomes of FORT, FOI, implantation rate and clinical pregnancy rate in the 2 groups will also be compared. 
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