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A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Compacting embryo transferring
Non- compacting embryo transferring
Sponsored by
Vietnam National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • IVF treatment for infertility
  • Controlled ovarian hyperstimulation by GnRH antagonist protocol.
  • IVF cycles ≤2
  • Eligible for transfer of 2 embryos on day 3
  • Have at least 2 embryos which are 7-9 cells and fragmentation ≤20%, that had either early compaction or still on cleavage stage

Exclusion Criteria:

  • Oocyte donation cycles
  • Abnormal uterine
  • Using GnRH agonist for triggering.

Sites / Locations

  • My Duc HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early compaction embryo group

Cleavage stage embryo group

Arm Description

patients have compacting embryos at 66±2 hours after ICSI

patients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI

Outcomes

Primary Outcome Measures

The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.

Secondary Outcome Measures

Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography
Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).
Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy
Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation

Full Information

First Posted
November 25, 2016
Last Updated
July 12, 2017
Sponsor
Vietnam National University
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1. Study Identification

Unique Protocol Identification Number
NCT02987075
Brief Title
A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium
Official Title
A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam National University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo transfer at 66±2 hours after ICSI using single step culture medium
Detailed Description
A prospective cohort study to compare the outcomes of transferring the early compacting and the cleavage day 3 embryos. All participants were treated with a gonadotropin-releasing antagonist protocol according to local protocol. Recombinant follicle stimulating hormone was given for five days starting on the second or third day of the menstrual cycle at a starting dose individualized for each participant as follows: 150, 225 or 300 IU/day, respectively, in participants with anti-Müllerian hormone levels of <2.1 ng/mL, 0.7-2.1 ng/mL or <0.7 ng/mL. This dosage could then be titrated based on clinical judgement of the investigator. Follicular development was monitored using ultrasound scanning and measurement of estradiol and progesterone levels, starting on day five of stimulation; scanning and hormonal measurements were repeated every two to three days, depending on follicle size. An antagonist was routinely used on day five until the day of human chorionic gonadotropin administration. Criteria for administration of recombinant human chorionic gonadotropin (5,000 IU) was the presence of at least two leading follicles of 17 mm in diameter. Oocyte retrieval was performed 36 hours after recombinant human chorionic gonadotropin administration. Insemination was performed using intra-cytoplasmic sperm injection at three to four hours after oocyte retrieval; only matured oocytes were inseminated. Fertilization check was performed under inverted microscope at 16-18 hours after insemination. Embryo evaluation was performed on day 3 at fixed time point after fertilization (66±2 hours) using the Istanbul consensus. As a rule, two useful embryos are transferred in patients if having either early compaction or still on cleavage stage. Early compaction embryo transfer group: transfer of 2 utilizable compacting embryos. Cleavage stage embryo transfer group: transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation. Embryo transfer was performed using a soft catheter by a standard technique under ultrasound guidance. Intensive luteal phase support was provided using progesterone gel and estradiol. At least 18 days after OPU, a urinary pregnancy test is performed. If the pregnancy test is positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and 42 days (5 to 6 weeks) after ET to confirm a clinical pregnancy and at least 70 days (≥10 weeks) after ET to confirm an ongoing pregnancy. Other clinical parameters will also be evaluated: serum hormone levels, fertilization rate, number and quality of day 3 embryos, implantation rate, ectopic pregnancy rate and miscarriage rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early compaction embryo group
Arm Type
Other
Arm Description
patients have compacting embryos at 66±2 hours after ICSI
Arm Title
Cleavage stage embryo group
Arm Type
Other
Arm Description
patients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI
Intervention Type
Other
Intervention Name(s)
Compacting embryo transferring
Intervention Description
transfer of 2 utilizable compacting embryos
Intervention Type
Other
Intervention Name(s)
Non- compacting embryo transferring
Intervention Description
transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
Primary Outcome Measure Information:
Title
The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography
Time Frame
7 weeks
Title
Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).
Time Frame
7 weeks
Title
Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy
Time Frame
7 weeks
Title
Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation
Time Frame
12 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IVF treatment for infertility Controlled ovarian hyperstimulation by GnRH antagonist protocol. IVF cycles ≤2 Eligible for transfer of 2 embryos on day 3 Have at least 2 embryos which are 7-9 cells and fragmentation ≤20%, that had either early compaction or still on cleavage stage Exclusion Criteria: Oocyte donation cycles Abnormal uterine Using GnRH agonist for triggering.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuong M Ho, MD
Phone
+84 906633377
Email
homanhtuong@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anh H Dang, Msc
Phone
+ 84 908 302412
Email
anh.dh@myduchospital.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuong M Ho, MD
Organizational Affiliation
CGRH - Vietnam National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
My Duc Hospital
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinh Q Dang, MD
Phone
+84908225481
Email
bsvinh.dq@myduchospital.vn
First Name & Middle Initial & Last Name & Degree
Bao G Huynh, MSc
Phone
+ 84 908609348
Email
bao.hg@myduchospital.vn

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium

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