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Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Embryo Transfer on Pregnancy Outcomes in Frozen Embryo Transfer Cycles.

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intra uterine injection of tissue culture medium containing HCG+ET
Intra uterine injection of tissue culture medium +ET
ET
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring human chorionic gonadotropin (hCG), implantation rate intrauterine hCG clinical pregnancy rate frozen embryo transfer cycles

Eligibility Criteria

19 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with history of one fresh embryo transfer failure
  2. Patients with Primary infertility
  3. Patients with at least one embryo with excellent quality

Exclusion Criteria:

  1. Female age over 40 years old
  2. Severe male factor (Azoospermia)
  3. Endometriosis diagnosis and the presence of hydrosalpinges
  4. Uterine factor ( polyps, myoma and previous myomectomy, …)
  5. Patients with polycystic ovarian syndrome diagnosis
  6. Cases with pre-implantation genetic diagnosis (PGD)indication
  7. Cases with difficult embryo transfer or use of Tenaculum
  8. Patients with repeated implantation failures and repeated miscarriages.
  9. Female smokers

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

experimental group

placebo group

control group

Arm Description

The patients who receive 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine, approximately 7 minutes before embryo transfer.

The patients who receive only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.

The patients for whom the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups

Outcomes

Primary Outcome Measures

Implantation rate
Evaluation of Implantation rate 6 weeks after embryo transfer.

Secondary Outcome Measures

Pregnancy loss
Evaluation of pregnancy loss under 12 weeks of gestational age.
Early miscarriage rate
Evaluation of Early miscarriage rate under 12 weeks of gestational age.
Late miscarriage rate
Evaluation of late miscarriage rate under 20 weeks of gestational age.

Full Information

First Posted
July 4, 2016
Last Updated
December 26, 2018
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02825108
Brief Title
Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Embryo Transfer on Pregnancy Outcomes in Frozen Embryo Transfer Cycles.
Official Title
Evaluation the Effect of Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Frozen Embryo Transfer on Implantation and Clinical Pregnancy Rates Per Cycle , Phase 3 Randomized Double Blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study is designed as a pilot study with 50 patients in each group. Data collection form will be filled by the researcher who does not know the type of intervention in each group
Detailed Description
This randomized double blinded clinical trial is conducted to evaluate the effect of intrauterine injection of human chorionic gonadotropin (hCG) before frozen embryo transfer (ET). The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute. The study is performed according to the Declaration of Helsinki for medical research. All participants provide informed consent after explaining the purpose of the study. All the patients with primary infertility who have only one fresh implantation failure and undergoing frozen embryo transfer cycles are enrolled. In all patients, endometrial preparation is performed by hormonal replacement method. In this way, endometrial preparation is started from the second or third day of menstrual cycle with daily administration of 6 mg oral estradiol valerate (Estraval®, Aburaihan CO, Tehran, Iran) for 8 days. After 8 days of estradiol administration, if favourable thickness of endometrium (≥ 8 mm) is confirmed by ultrasound, estradiol valerate is continued with the same dose and 50 mg progesterone (Progestin®, Aburaihan Pharmaceutical. Co., Tehran, Iran) intramuscularly is administered for 3 days and then embryos are transferred. Otherwise the dosage of estradiol is increased to 8 mg/day until the favourable thickness of endometrium be achieved. In the Embryo transfer day, the eligible patients are randomized using sealed opaque envelopes into three groups. In all study groups, the patient is put in the lithotomy position, and the cervix is visualized using Cusco's speculum. The cervical mucous is wiped out using a sterile piece of gauze, and then the mucous is partially removed by gentle suction with a 1-mL syringe. Embryo transfer is performed using a soft catheter (Labotec, Gottingen Germany). After the catheter is passed the internal cervical os; in group A (experimental group) 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine. In group B (the placebo group) only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine. In both groups, approximately 7 minutes after injection, the embryos are loaded into another ET catheter and are transferred into the uterine cavity. In group C (the control group), the ET is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups. According to the patients' age, up to 3 frozen-thawed Embryos are thawed and transferred at cleavage stage. Hormone therapy is continued until pregnancy test (2 weeks after ET) is performed and in case of positive pregnancy, administration of estradiol valerate and progesterone continued by 10 and 12 weeks of gestation. Chemical pregnancy is defined by a rising hCG level in serum without the detection of a gestational sac. Clinical pregnancy is diagnosed by the presence of a gestational sac with fetal heart in vaginal ultrasonography. The miscarriage rate is defined as the loss of pregnancy before 20 weeks' gestational age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
human chorionic gonadotropin (hCG), implantation rate intrauterine hCG clinical pregnancy rate frozen embryo transfer cycles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The patients who receive 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine, approximately 7 minutes before embryo transfer.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
The patients who receive only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.
Arm Title
control group
Arm Type
Other
Arm Description
The patients for whom the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups
Intervention Type
Drug
Intervention Name(s)
Intra uterine injection of tissue culture medium containing HCG+ET
Intervention Description
40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine, approximately 7 minutes before embryo transfer.
Intervention Type
Drug
Intervention Name(s)
Intra uterine injection of tissue culture medium +ET
Intervention Description
) only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.
Intervention Type
Procedure
Intervention Name(s)
ET
Intervention Description
the embryo transfer ( ET) is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.
Primary Outcome Measure Information:
Title
Implantation rate
Description
Evaluation of Implantation rate 6 weeks after embryo transfer.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pregnancy loss
Description
Evaluation of pregnancy loss under 12 weeks of gestational age.
Time Frame
12 weeks
Title
Early miscarriage rate
Description
Evaluation of Early miscarriage rate under 12 weeks of gestational age.
Time Frame
12 weeks
Title
Late miscarriage rate
Description
Evaluation of late miscarriage rate under 20 weeks of gestational age.
Time Frame
20 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with history of one fresh embryo transfer failure Patients with Primary infertility Patients with at least one embryo with excellent quality Exclusion Criteria: Female age over 40 years old Severe male factor (Azoospermia) Endometriosis diagnosis and the presence of hydrosalpinges Uterine factor ( polyps, myoma and previous myomectomy, …) Patients with polycystic ovarian syndrome diagnosis Cases with pre-implantation genetic diagnosis (PGD)indication Cases with difficult embryo transfer or use of Tenaculum Patients with repeated implantation failures and repeated miscarriages. Female smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tahere Madani, MD
Organizational Affiliation
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maryam Hafezi, MD
Organizational Affiliation
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arezoo Arabipour, M.S.c
Organizational Affiliation
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://royaninstitute.org
Description
Related Info
URL
https://doi.org/10.1007/s00404-018-4752-2
Description
Publication

Learn more about this trial

Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Embryo Transfer on Pregnancy Outcomes in Frozen Embryo Transfer Cycles.

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