An interventional study of standard IVF and In vitro maturation in PCOS, sponsored by Jie Qiao. Status unknown at 1 site in China. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Jie Qiao · Not applicable, Interventional, and Treatment
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Among 107 studies in Polycystic Ovary Syndrome with a site in China — 29 open to participants now, 33 under way, none of them phase 3. Polycystic Ovary Syndrome · China.
Among the 107 studies in Polycystic Ovary Syndrome with a site in China, this one is the 15th largest by enrollment of the 86 interventional ones that give a count, is one of 6 that started in 2018, is one of 51 with no phase, and was the 31st registered.
958 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
Browse Polycystic Ovary Syndrome studies →29 of the 107 studies in Polycystic Ovary Syndrome with a site in China are open now. Recruiting first, the newest first:
Peking University Third Hospital · Sites in China
Ages 18–40 · Women only
Women's Hospital School Of Medicine Zhejiang University · Sites in China
Ages 18–40 · Women only · Healthy volunteers
Shanghai Zhongshan Hospital · Sites in China
Ages 18–40 · Women only
Shanghai First Maternity and Infant Hospital · Sites in China
Ages 19–40 · Women only
Sichuan Provincial People's Hospital · Sites in China
Ages 18–40 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 119 Polycystic Ovary Syndrome studies recruiting now, 11 (9%) set no upper age limit and 105 (88%) stop at 75 or younger; 23 take children under 18; 41 take healthy volunteers.
This study: 20 Years to 38 Years · female · no healthy volunteers.
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107 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 12 · Phase 3 7 · Phase 4 14
First in 2008; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 350 is above the median of 70 across 699 interventional studies indexed under Polycystic Ovary Syndrome.
Median enrollment 100 across the 86 interventional studies, 300 across the 21 observational. Of the 37 that completed or were terminated, 2 (5%) have results posted.
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2 of 107 have an industry lead sponsor. The 10 most frequent:
Jie Qiao is the lead sponsor of 2 studies on the registry; none are open to participants now.
Jie Qiao has 1 study filed under Polycystic Ovary Syndrome — fewer than ten, so there is no comparison to draw.
4 of the studies in Polycystic Ovary Syndrome with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07739940Guangdong Women and Children HospitalClinical Research Cohort for Polycystic Ovary Syndrome | 2026-12-01 |
| NCT07739953Guangdong Women and Children HospitalDevelopment and Clinical Application of ApoC3 Protein as a Predictive Biomarker for Insulin Resistance in Polycystic Ovary Syndrome | 2026-12-31 |
| NCT06775093Peking University Third HospitalEffects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity | 2026-12-31 |
| NCT07616037Shanghai Zhongshan HospitalEfficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS | 2027-06 |
Add all 4 to your calendar (.ics) → With an account.
Among the 107 studies in Polycystic Ovary Syndrome with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A single center, prospective, open-label, non-inferiority randomized controlled clinical trials (1:1 treatment ratio) regarding pregnancy outcomes between IVM and standard IVF among infertility couples with PCOS in China.
A single center, randomized controlled clinical trial will enroll 350 couples with PCOS undergoing their first cycle of IVF. The participation in this study will be approximately 2 years with a total of 7 visits from the cycle beginning, pregnancy to delivery. On day 2 or day 3 following the onset of menstrual bleeding, eligible patients will be allocated to two groups at a ratio of 1:1- IVM protocol, and standard IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group A will receive standard IVF procedure. Other standard assisted reproductive treatments are similar and parallel between two groups.
Procedure: standard IVF
On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group B will receive IVM procedure.Other standard assisted reproductive treatments are similar and parallel between two groups.
Drug: In vitro maturation
Ovarian stimulation will be performed by a standard protocol using gonadotrophin-releasing hormone antagonist (GnRH-ant) in association with recombinant FSH (rFSH) and human chorionic gonadotrophin (hCG).Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be inseminated using ICSI or conventional IVF according to the seman analysis. All embryos will be cultured to blastocyst stage and be vitrified.
Controlled ovarian stimulation protocol will not performed in this group patients. Transvaginal ultrasound scanning was examined on natural cycle to monitor the follicle size in group B participants. Oocyte retrieval was scheduled once the endometrium had reached at least 6 mm in thickness and there was no follicle larger than 10 mm. After oocyte retrieval, the COCs will be cultured for 28-32h in special IVM media in order to get the matured oocytes. All the metaphase II (MII) oocytes were inseminated by means of intracytoplasmic sperm injection (ICSI). All embryos will be cultured to blastocyst stage and be vitrified.
Also known as: IVM
the proportion of ongoing pregnancy leading to live birth
number of ongoing pregnancy leading to live birth resulting from the first oocyte retrieval cycle after the randomization ( 6 month) divided by the number of patients with oocyte retrieval
Time frame: after 22 weeks of gestation
implantation
Number of gestational sacs observed per embryo transferred
Time frame: 28 days after embryo transfer
clinical pregnancy
one or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 7 weeks after embryo transfer (including clinical documented ectopic pregnancy)
Time frame: 7 weeks after embryo transfer
Miscarriage
Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age
Time frame: 28 weeks of gestation
Preterm birth
Birth of a fetus delieved after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy
Time frame: 28-37 weeks of pregnancy
Birth weight
Including low birth weight (defined as weight \<2500 gm at birth), very low birth weight (defined as \< 1500 gm at birth), high birth weight (defined as \> 4000 gm at birth) and very high birth weight (defined as \> 4500 gm at birth).
Time frame: within 2 weeks after live birth
Large for gestational age
Birth weight \>90th centile for gestation, based on standardised ethnicity based charts.
Time frame: within 2 weeks after live birth
Small for gestational age
Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.
Time frame: within 2 weeks after live birth
Congenital anomaly
Any congenital anomaly will be included diagnosed by physical examinition, ultrasound or necessary testing (including CT, X-ray etc.)
Time frame: within 2 weeks after live birth
Perinatal mortality
Fetal or neonatal death occurring during late pregnancy (at 28 completed weeks of gestational age and later), during childbirth, or up to seven completed days after birth.
Time frame: within 2 weeks after live birth
Moderate/severe ovarian hyperstimulation syndrome (OHSS)
exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate, or severe according to the degree of abdominal distention, ovarian enlargement and respiratory hemodynamic, and metabolic complications. Diagosised by ultrasound, blood testing and physical examination according the Chinese Medical Guildline.
Time frame: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assesses about 14-16 days.
Started Mar 2018 (actual). Primary completion is estimated for Jun 2020, 27 months after the start.
Of 203 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 27 months is above that.
Counting every sponsor, half of 218 studies reached it within 18 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin
Jie Qiao