Back to resultsIVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS
Primary Purpose
PCOS
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
standard IVF
In vitro maturation
Sponsored by
About this trial
This is an interventional treatment trial for PCOS focused on measuring in vitro maturation, polycystic ovarian syndrome, oocyte
Eligibility Criteria
Inclusion Criteria:
- Infertile couples scheduled for their first IVF cycle.
- Women diagonosed with polycystic ovarian syndrome.
- Voluntary participation and informed consent obtained.
Exclusion Criteria:
- Couple with contraindication for IVF or ICSI.
- Couples receiving donor sperm or donor eggs.
- Couples with indications or have plan to receive PGD and PGS.
- Sperm analysis diagnosed as azoospermia;
- Either male partner or female partner with an abnormal chromosome karyotype (chromosome polymorphisms was not included).
- Women who have undergone unilateral ovariectomy.
Sites / Locations
- Peking University third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
standard IVF
In vitro maturation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
implantation
Number of gestational sacs observed per embryo transferred
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)
Miscarriage
Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age
Preterm birth
Birth of a fetus delieved after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing 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).
Large for gestational age
Birth weight >90th centile for gestation, based on standardised ethnicity based charts.
Small for gestational age
Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.
Congenital anomaly
Any congenital anomaly will be included diagnosed by physical examinition, ultrasound or necessary testing (including CT, X-ray etc.)
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03463772
Brief Title
IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS
Official Title
In Vitro Maturation Versus Standard in Vitro Fertilization in Infertile Patients Diagnosed With Polycystic Ovaries Syndrome: a Study Protocol for a Single-center Prospective, Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie Qiao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
Keywords
in vitro maturation, polycystic ovarian syndrome, oocyte
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients that have provided informed consent will be randomized to either IVM or standard IVF. Randomization and allocation of patients to study groups will be performed on the day 2 or 3 of the menstrual cycle. Randomization will be centrally controlled by administrative staff in the trial center, who are not involved in the treatment procedure. When there is an eligible participant to be enrolled into the study, nurses from the specific site will log in the trial center to get allocation of patients according to a computer-generated randomization list in a 1:1 ratio, with a variable block size of 2, 4 or 8 and stratified by center.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard IVF
Arm Type
Active Comparator
Arm Description
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.
Arm Title
In vitro maturation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
standard IVF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
In vitro maturation
Other Intervention Name(s)
IVM
Intervention Description
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.
Primary Outcome Measure Information:
Title
the proportion of ongoing pregnancy leading to live birth
Description
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
Secondary Outcome Measure Information:
Title
implantation
Description
Number of gestational sacs observed per embryo transferred
Time Frame
28 days after embryo transfer
Title
clinical pregnancy
Description
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
Title
Miscarriage
Description
Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age
Time Frame
28 weeks of gestation
Title
Preterm birth
Description
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
Title
Birth weight
Description
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
Title
Large for gestational age
Description
Birth weight >90th centile for gestation, based on standardised ethnicity based charts.
Time Frame
within 2 weeks after live birth
Title
Small for gestational age
Description
Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.
Time Frame
within 2 weeks after live birth
Title
Congenital anomaly
Description
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
Title
Perinatal mortality
Description
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
Title
Moderate/severe ovarian hyperstimulation syndrome (OHSS)
Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infertile couples scheduled for their first IVF cycle.
Women diagonosed with polycystic ovarian syndrome.
Voluntary participation and informed consent obtained.
Exclusion Criteria:
Couple with contraindication for IVF or ICSI.
Couples receiving donor sperm or donor eggs.
Couples with indications or have plan to receive PGD and PGS.
Sperm analysis diagnosed as azoospermia;
Either male partner or female partner with an abnormal chromosome karyotype (chromosome polymorphisms was not included).
Women who have undergone unilateral ovariectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Qiao
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34849920
Citation
Zheng X, Guo W, Zeng L, Zheng D, Yang S, Xu Y, Wang L, Wang R, Mol BW, Li R, Qiao J. In vitro maturation without gonadotropins versus in vitro fertilization with hyperstimulation in women with polycystic ovary syndrome: a non-inferiority randomized controlled trial. Hum Reprod. 2022 Jan 28;37(2):242-253. doi: 10.1093/humrep/deab243.
Results Reference
derived
PubMed Identifier
32295778
Citation
Zheng X, Guo W, Zeng L, Zheng D, Yang S, Wang L, Wang R, Mol BW, Li R, Qiao J. Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial. BMJ Open. 2020 Apr 14;10(4):e035334. doi: 10.1136/bmjopen-2019-035334.
Results Reference
derived
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IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS
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