Clinical Pregnancy RateNCT02496754
Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization
A study testing GnRH-a and GnRH-anta in people with Clinical Pregnancy Rate and Ovulation Induction, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly. Read more about this study
- Who is it for?
- Ages 22 to 38 years, women only
- Conditions the study is for
- Clinical Pregnancy Rate, Ovulation Induction, IVF
- What is being tested?
- GnRH-a and GnRH-anta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,266 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2024
- 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 22 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- First IVF cycle;
- With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
- With normal uterine.
- PCOS women according to Rotterdam criteria
Who cannot join
- Pre-implantation genetic diagnosis cycles;
- Oocyte donation or sperm donation cycles.
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization: a Prospective Randomized Controlled Trial
Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly.
At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in arou Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation.
The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.
Read the detailed description
The primary outcome is clinical prengancy rate. Secondary outcome is cumulative live birth rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.
- Conditions
- Clinical Pregnancy Rate, Ovulation Induction, IVF
- Being tested
- GnRH-a, GnRH-anta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH-aDrug
In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed.
GnRH-antaDrug
In control group, patients use GnRH-antagonist. Patients' serum or follicle fluid will be collected if needed.
| Study group | Role | What they receive |
|---|---|---|
| New protocol group | Experimental | Use long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated. Receives: Drug: GnRH-a |
| GnRH-antagonist | Active comparator | In the GnRH antagonist protocol, Gn was injected from day 2-3 of the menstrual cycle and GnRH antagonist (Cetrotide; 0.25 mg) was added daily from day 6 of stimulation. When 2 dominant follicle ≥ 18 mm or three follicles ≥ 17 mm, recombinant human chorionic gonadotropin (hCG) was injected. Receives: Drug: GnRH-anta |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
Measured: 5 weeks after embryo transfer
Secondary outcomes (3)
cumulative live birth rate
Measured: 2 years after oocyte retrivial
Number of oocytes retrieved
Measured: 1 day at oocyte retrieved day
2 pronucleus (2PN) fertilization rate
Number of 2PN/Matured oocytes
Measured: 48 hours after oocyte retrieved day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2022
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clinical Pregnancy RateStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yingpu Sun, M.D, Principal investigator, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496754
- Sponsor's protocol ID
- RMCZZU-New protocol
- Status last verified
- Mar 2025
- First submitted
- 8 Jul 2015
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2.
PubMed 16437491Niu Z, Chen Q, Sun Y, Feng Y. Long-term pituitary downregulation before frozen embryo transfer could improve pregnancy outcomes in women with adenomyosis. Gynecol Endocrinol. 2013 Dec;29(12):1026-30. doi: 10.3109/09513590.2013.824960. Epub 2013 Sep 5.
PubMed 24006906
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02496754
- Acronym / sponsor ID
- RMCZZU-New protocol
- Conditions
- Clinical Pregnancy Rate, Ovulation Induction, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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.
Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly.
At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in arou Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation.
The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.
Detailed description
The primary outcome is clinical prengancy rate. Secondary outcome is cumulative live birth rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New protocol group | Experimental | Drug: GnRH-aUse long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated. |
| GnRH-antagonist | Active comparator | Drug: GnRH-antaIn the GnRH antagonist protocol, Gn was injected from day 2-3 of the menstrual cycle and GnRH antagonist (Cetrotide; 0.25 mg) was added daily from day 6 of stimulation. When 2 dominant follicle ≥ 18 mm or three follicles ≥ 17 mm, recombinant human chorionic gonadotropin (hCG) was injected. |
Who may qualify
- Ages
- 22 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- First IVF cycle;
- With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
- With normal uterine.
- PCOS women according to Rotterdam criteria
Key exclusion criteria (2 listed)
- Pre-implantation genetic diagnosis cycles;
- Oocyte donation or sperm donation cycles.
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-aIn experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed. | Drug | New protocol group |
| GnRH-antaIn control group, patients use GnRH-antagonist. Patients' serum or follicle fluid will be collected if needed. | Drug | GnRH-antagonist |
Primary outcome
clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
3 secondary outcomes
cumulative live birth rate
Time frame: 2 years after oocyte retrivial
Number of oocytes retrieved
Time frame: 1 day at oocyte retrieved day
2 pronucleus (2PN) fertilization rate
Time frame: 48 hours after oocyte retrieved day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Background: PubMed 16437491Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2.
- Background: PubMed 24006906Niu Z, Chen Q, Sun Y, Feng Y. Long-term pituitary downregulation before frozen embryo transfer could improve pregnancy outcomes in women with adenomyosis. Gynecol Endocrinol. 2013 Dec;29(12):1026-30. doi: 10.3109/09513590.2013.824960. Epub 2013 Sep 5.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yingpu Sun, M.D principal investigator
Zhengzhou University
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-a and GnRH-anta in people with Clinical Pregnancy Rate and Ovulation Induction, run by The First Affiliated Hospital of Zhengzhou University 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical pregnancy rate (time frame: 5 weeks after embryo transfer). 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 NCT02496754, which also lists 2 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 5 Mar 2025.