Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gonadotropin-Releasing Hormone Analogue
Gonadotropin releasing hormone antagonist
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria:
- Unexplained infertility.
- Tubal factor. Included treated hydrosalpinx and pyosalpinx
- first cycle .
- Body mass index: 18-29.
- Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1.
- Antral follicular count: more than 5 follicles in one ovary.
- combined factors .
- Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.
Exclusion Criteria:
- Patients with Endometriosis.
- Azoospermic male.
- Body mass index more than 29.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
agonist group
antagonist group
Arm Description
Triptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
•Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .
Outcomes
Primary Outcome Measures
number of maturated oocyte and good quality embryoes
Secondary Outcome Measures
clinical pregnancy outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03139474
Brief Title
Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality
Official Title
Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality in Intracytoplasmic Sperm Injection Cycles.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone analogues are co-administered in order to prevent premature luteinizing hormone surges. Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without using gonadotrophin-releasing hormone analogues .
Avoiding the adverse effects of elevated luteinizing hormone levels, first gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes gonadotrophin suppression through down-regulation and desensitization of the gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short period of gonadotrophin hypersecretion .
Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion. Several advantageous effects of cetrorelix were established , and these effects seemed to be independent from the type of antagonist used for luteinizing hormone-suppression.The quality of oocytes and developing preembryos is one of the most relevant factors determining the success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing effects are necessary to know.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
agonist group
Arm Type
Active Comparator
Arm Description
Triptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
Arm Title
antagonist group
Arm Type
Active Comparator
Arm Description
•Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .
Intervention Type
Drug
Intervention Name(s)
Gonadotropin-Releasing Hormone Analogue
Intervention Description
Triptorelin at a dose 1 mg per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
Intervention Type
Drug
Intervention Name(s)
Gonadotropin releasing hormone antagonist
Intervention Description
antagonist group :Multiple dose gonadotrophin-releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .We will give them gonadotrophin for 5 days , Triggering by Human Chorionic Gonadotrophin will be administered for each group when size of follicle reach > 17 millimeter .Oocytes will retrieved by transvaginal ultrasound , 34-36 hours after Human Chorionic Gonadotrophin administration .
Primary Outcome Measure Information:
Title
number of maturated oocyte and good quality embryoes
Time Frame
14 days
Secondary Outcome Measure Information:
Title
clinical pregnancy outcome
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unexplained infertility.
Tubal factor. Included treated hydrosalpinx and pyosalpinx
first cycle .
Body mass index: 18-29.
Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1.
Antral follicular count: more than 5 follicles in one ovary.
combined factors .
Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.
Exclusion Criteria:
Patients with Endometriosis.
Azoospermic male.
Body mass index more than 29.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality
We'll reach out to this number within 24 hrs