InfertilityNCT03680053
Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF
A study testing Duphaston and Cetrorelix in people with Infertility and ART, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial summary
A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable… Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Infertility, ART
- What is being tested?
- Duphaston and Cetrorelix
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2020to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age of women <43 years at the time of ovarian stimulation for IVF
- Antral follicle count (AFC) on day 2-5 of the period≥5
Who cannot join
- Presence of a functional ovarian cyst with E2>100 pg/mL
- Recipient of oocyte donation
- Undergoing preimplantation genetic testing
- Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the Gonadotrophin Releasing Hormone Antagonist Protocol in Patients Undergoing in Vitro Fertilization
A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization
Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF?
Read more
Design This is a randomized controlled trial.
Research plan
Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria.
Intervention: Women will receive oral dydrogesterone 20mg daily from Day 3 till the day of ovulation trigger.
Comparator: Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
Outcomes: The primary outcome is the live birth rate the first FET.
Ovarian stimulation, egg retrieval, embryos frozen and frozen embryo transfer will be performed according to the standard operating procedures of the centres.
- Conditions
- Infertility, ART
- Being tested
- Duphaston, Cetrorelix
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuphastonDrug
Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.
CetrorelixDrug
Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
| Study group | Role | What they receive |
|---|---|---|
| PPOS group | Experimental | Ovarian stimulation will use the progestin-primed ovarian stimulation (PPOS) protocol.Women will receive progesterone (oral duphaston 20mg) daily from Day 3 till the day of ovulation trigger. Receives: Drug: Duphaston |
| Antagonist group | Active comparator | Ovarian stimulation will use the antagonist protocol. Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. Receives: Drug: Cetrorelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate of the first FET live birth rate of the first FET live birth rate
live birth rate of the first FET
Measured: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Secondary outcomes (17)
Serum estradiol level
Serum estradiol level on the day of hCG trigger
Measured: on the day of hCG trigger, an average of 2 weeks after randomization
Serum progesterone level
Serum progesterone level on the day of hCG trigger
Measured: on the day of hCG trigger, an average of 2 weeks after randomization
Serum LH level
Serum LH level on the day of hCG trigger
Measured: on the day of hCG trigger, an average of 2 weeks after randomization
Serum FSH level
Serum FSH level on Day 2 of the period
Measured: on the day of hCG trigger, an average of 2 days after randomization
oocyte retrieved number
Measured: the number of oocyte retrieved, an average of 2 weeks after randomization
embryo number
Measured: the number of embryo, an average of 3 weeks after randomization
positive hCG level
defined with the result of serum β-hCG ≥10 mIU/mL
Measured: a blood hCG test is performed 14 days after the FET, up to 14 days
clinical pregnancy rate
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
Measured: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
ongoing pregnancy rate
presence of a fetal pole with pulsation at 12 weeks of gestation
Measured: viable pregnancy beyond gestation 12 weeks, up to 12 weeks
implantation rate
number of gestational sacs per embryo transferred
Measured: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
multiple pregnancy rate
more than one intrauterine sacs on scanning
Measured: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
miscarriage rate
defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.
Measured: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
ectopic pregnancy rate
pregnancy outside the uterine cavity
Measured: ectopic pregnancy during first trimester, up to 12 weeks
birth weight
birth weight of the baby delivered
Measured: a live birth after 22 weeks gestation, through study completion, an average of 1 year
rate of participants with adverse events
adverse events during COH
Measured: adverse events during COH in an average of 1 month
rate of obstetric complications
obstetric complications during pregnancy or delivery. The information will be acquired by contacting all the participants through phone
Measured: obstetric complications during pregnancy or delivery in an average of 1 year
rate of fetal or congenital defects
fetal or congenital defects found during pregnancy or delivery. The information will be acquired by contacting all the participants through phone
Measured: fetal or congenital defects found during pregnancy or delivery in an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start10 Apr 2020
- Primary completion10 May 2025
- Study completion10 May 2025
Why it stopped: The study was terminated due to difficulty in recruiting patients.
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 InfertilityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- XIAOXI SUN, PHD, Principal investigator, Shanghai JiAi Genetics & IVF Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680053
- Sponsor's protocol ID
- JIAI 2018-08
- Status last verified
- Aug 2024
- First submitted
- 17 Sep 2018
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication).
Publications
Al-Inany HG, Youssef MA, Aboulghar M, Broekmans F, Sterrenburg M, Smit J, Abou-Setta AM. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2011 May 11;(5):CD001750. doi: 10.1002/14651858.CD001750.pub3.
PubMed 21563131Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.
PubMed 25956370Dong J, Wang Y, Chai WR, Hong QQ, Wang NL, Sun LH, Long H, Wang L, Tian H, Lyu QF, Lu XF, Chen QJ, Kuang YP. The pregnancy outcome of progestin-primed ovarian stimulation using 4 versus 10 mg of medroxyprogesterone acetate per day in infertile women undergoing in vitro fertilisation: a randomised controlled trial. BJOG. 2017 Jun;124(7):1048-1055. doi: 10.1111/1471-0528.14622.
PubMed 28276192Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.
PubMed 28062551Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.
PubMed 29300975
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the Gonadotrophin Releasing Hormone Antagonist Protocol in Patients Undergoing in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT03680053
- Acronym / sponsor ID
- JIAI 2018-08
- Conditions
- Infertility, ART
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to difficulty in recruiting patients.
- Enrolment
- 220 participants (actual)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 21 Sep 2018 (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.
A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization
Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF?
Design This is a randomized controlled trial.
Research plan
Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria.
Intervention: Women will receive oral dydrogesterone 20mg daily from Day 3 till the day of ovulation trigger.
Comparator: Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
Outcomes: The primary outcome is the live birth rate the first FET.
Ovarian stimulation, egg retrieval, embryos frozen and frozen embryo transfer will be performed according to the standard operating procedures of the centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPOS group | Experimental | Drug: DuphastonOvarian stimulation will use the progestin-primed ovarian stimulation (PPOS) protocol.Women will receive progesterone (oral duphaston 20mg) daily from Day 3 till the day of ovulation trigger. |
| Antagonist group | Active comparator | Drug: CetrorelixOvarian stimulation will use the antagonist protocol. Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age of women <43 years at the time of ovarian stimulation for IVF
- Antral follicle count (AFC) on day 2-5 of the period≥5
Key exclusion criteria (4 listed)
- Presence of a functional ovarian cyst with E2>100 pg/mL
- Recipient of oocyte donation
- Undergoing preimplantation genetic testing
- Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
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 |
|---|---|---|
| DuphastonWomen will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger. | Drug | PPOS group |
| CetrorelixWomen will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. | Drug | Antagonist group |
Primary outcome
live birth rate of the first FET live birth rate of the first FET live birth rate
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
live birth rate of the first FET
17 secondary outcomes
Serum estradiol level
Time frame: on the day of hCG trigger, an average of 2 weeks after randomization
Serum progesterone level
Time frame: on the day of hCG trigger, an average of 2 weeks after randomization
Serum LH level
Time frame: on the day of hCG trigger, an average of 2 weeks after randomization
Serum FSH level
Time frame: on the day of hCG trigger, an average of 2 days after randomization
oocyte retrieved number
Time frame: the number of oocyte retrieved, an average of 2 weeks after randomization
embryo number
Time frame: the number of embryo, an average of 3 weeks after randomization
positive hCG level
Time frame: a blood hCG test is performed 14 days after the FET, up to 14 days
clinical pregnancy rate
Time frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
ongoing pregnancy rate
Time frame: viable pregnancy beyond gestation 12 weeks, up to 12 weeks
implantation rate
Time frame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
multiple pregnancy rate
Time frame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
miscarriage rate
Time frame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
ectopic pregnancy rate
Time frame: ectopic pregnancy during first trimester, up to 12 weeks
birth weight
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
rate of participants with adverse events
Time frame: adverse events during COH in an average of 1 month
rate of obstetric complications
Time frame: obstetric complications during pregnancy or delivery in an average of 1 year
rate of fetal or congenital defects
Time frame: fetal or congenital defects found during pregnancy or delivery in an average of 1 year
Results and safety
The study was stopped early (reason given: The study was terminated due to difficulty in recruiting patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 21563131Al-Inany HG, Youssef MA, Aboulghar M, Broekmans F, Sterrenburg M, Smit J, Abou-Setta AM. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2011 May 11;(5):CD001750. doi: 10.1002/14651858.CD001750.pub3.
- Background: PubMed 25956370Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.
- Background: PubMed 28276192Dong J, Wang Y, Chai WR, Hong QQ, Wang NL, Sun LH, Long H, Wang L, Tian H, Lyu QF, Lu XF, Chen QJ, Kuang YP. The pregnancy outcome of progestin-primed ovarian stimulation using 4 versus 10 mg of medroxyprogesterone acetate per day in infertile women undergoing in vitro fertilisation: a randomised controlled trial. BJOG. 2017 Jun;124(7):1048-1055. doi: 10.1111/1471-0528.14622.
- Background: PubMed 28062551Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.
- Background: PubMed 29300975Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication).
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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. This study is not recruiting at the moment.
XIAOXI SUN, PHD principal investigator
Shanghai JiAi Genetics & IVF Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duphaston and Cetrorelix in people with Infertility and ART, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 May 2025. 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 China. 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?
The study was stopped early (reason given: The study was terminated due to difficulty in recruiting patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate of the first FET live birth rate of the first FET live birth rate (time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year). 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 NCT03680053, 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 31 May 2025.