Clinical Pregnancy RateNCT03006406
Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis
A study testing Long term GnRH-a (3.75mg) in people with Clinical Pregnancy Rate, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary… Read more about this study
- Who is it for?
- Ages 22 to 42 years, women only
- Conditions the study is for
- Clinical Pregnancy Rate
- What is being tested?
- Long term GnRH-a (3.75mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2018
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- first IVF cycle;
- with normal ovarian reserve(FSH(10miu/ml； antral follicle count )3)
- with normal uterine
Who cannot join
- Pre-implantation genetic diagnosis cycles;
- Oocyte donation cycles
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yingpu Ms Sun, M.D,PhD, 86-13803841888, syp2008@vip.sina.com
Zhiqin Mr Bu, MD, 86-15981978863, rmczzu@126.com
About this study
Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with GnRH-a for 1, or 2 months.
- Conditions
- Clinical Pregnancy Rate
- Being tested
- Long term GnRH-a (3.75mg)
- Keywords
- endometriosis, long term GnRH-a
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term GnRH-a (3.75mg)Drug
patient in this group only receive GnRH-a 3.75 for pituitary down-regulation
| Study group | Role | What they receive |
|---|---|---|
| Long term GnRH-a for 1 month | Active comparator | patient in this group only receive GnRH-a 3.75 for 1 month Receives: Drug: Long term GnRH-a (3.75mg) |
| patient in this group only receive GnRH-a 3.75 for 2 month | Experimental | patient in this group only receive GnRH-a 3.75 for 2 month Receives: Drug: Long term GnRH-a (3.75mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: 5 weeks after embryo transfer
Secondary outcomes (2)
Number of oocytes retrieved
Measured: 1 day at oocyte retrieved day
2 pronucleus(2PN)fertilization rate
Number of 2PN/Matured oocytes
Measured: 48hours 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 posted30 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006406
- Sponsor's protocol ID
- ENDO-1
- Status last verified
- Dec 2016
- First submitted
- 28 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
van der Houwen LE, Mijatovic V, Leemhuis E, Schats R, Heymans MW, Lambalk CB, Hompes PG. Efficacy and safety of IVF/ICSI in patients with severe endometriosis after long-term pituitary down-regulation. Reprod Biomed Online. 2014 Jan;28(1):39-46. doi: 10.1016/j.rbmo.2013.09.027. Epub 2013 Oct 9.
PubMed 24262434Mijatovic V, Florijn E, Halim N, Schats R, Hompes P. Adenomyosis has no adverse effects on IVF/ICSI outcomes in women with endometriosis treated with long-term pituitary down-regulation before IVF/ICSI. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):62-5. doi: 10.1016/j.ejogrb.2010.02.047. Epub 2010 Apr 21.
PubMed 20409633Kong H, Hu L, Nie L, Yu X, Dai W, Li J, Chen C, Bu Z, Shi H, Wu Q, Guan Y, Sun Y. A multi-center, randomized controlled clinical trial of the application of a shortened protocol of long-acting Triptorelin down-regulated prior to IVF/ICSI among patients with endometriosis: A protocol. Reprod Health. 2018 Dec 20;15(1):213. doi: 10.1186/s12978-018-0639-8.
PubMed 30572916
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT03006406
- Acronym / sponsor ID
- ENDO-1
- Conditions
- Clinical Pregnancy Rate
- Keywords
- endometriosis, long term GnRH-a
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 30 Dec 2016 (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.
Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with GnRH-a for 1, or 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long term GnRH-a for 1 month | Active comparator | Drug: Long term GnRH-a (3.75mg)patient in this group only receive GnRH-a 3.75 for 1 month |
| patient in this group only receive GnRH-a 3.75 for 2 month | Experimental | Drug: Long term GnRH-a (3.75mg)patient in this group only receive GnRH-a 3.75 for 2 month |
Who may qualify
- Ages
- 22 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- first IVF cycle;
- with normal ovarian reserve(FSH(10miu/ml； antral follicle count )3)
- with normal uterine
Key exclusion criteria (2 listed)
- Pre-implantation genetic diagnosis cycles;
- Oocyte 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 |
|---|---|---|
| Long term GnRH-a (3.75mg)patient in this group only receive GnRH-a 3.75 for pituitary down-regulation | Drug | Long term GnRH-a for 1 month, patient in this group only receive GnRH-a 3.75 for 2 month |
Primary outcome
clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
2 secondary outcomes
Number of oocytes retrieved
Time frame: 1 day at oocyte retrieved day
2 pronucleus(2PN)fertilization rate
Time frame: 48hours after oocyte retrieved day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Background: PubMed 24262434van der Houwen LE, Mijatovic V, Leemhuis E, Schats R, Heymans MW, Lambalk CB, Hompes PG. Efficacy and safety of IVF/ICSI in patients with severe endometriosis after long-term pituitary down-regulation. Reprod Biomed Online. 2014 Jan;28(1):39-46. doi: 10.1016/j.rbmo.2013.09.027. Epub 2013 Oct 9.
- Background: PubMed 20409633Mijatovic V, Florijn E, Halim N, Schats R, Hompes P. Adenomyosis has no adverse effects on IVF/ICSI outcomes in women with endometriosis treated with long-term pituitary down-regulation before IVF/ICSI. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):62-5. doi: 10.1016/j.ejogrb.2010.02.047. Epub 2010 Apr 21.
- Derived from this study: PubMed 30572916Kong H, Hu L, Nie L, Yu X, Dai W, Li J, Chen C, Bu Z, Shi H, Wu Q, Guan Y, Sun Y. A multi-center, randomized controlled clinical trial of the application of a shortened protocol of long-acting Triptorelin down-regulated prior to IVF/ICSI among patients with endometriosis: A protocol. Reprod Health. 2018 Dec 20;15(1):213. doi: 10.1186/s12978-018-0639-8.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long term GnRH-a (3.75mg) in people with Clinical Pregnancy Rate, 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 3 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: status not confirmed, as of the sponsor's last update on 30 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huijuan Kong, M.D. (86-371-67966161, luckyjuanjuan819@126.com), or a site near the patient. 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 NCT03006406, which also lists 3 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 30 Dec 2016.