Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality

Infertility, Female Clinical Trial

Official title:

Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality in Intracytoplasmic Sperm Injection Cycles.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03139474
• Other study ID #: HYY
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: May 2, 2017
• Last updated: May 2, 2017
• Start date: June 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

1. Unexplained infertility.

2. Tubal factor. Included treated hydrosalpinx and pyosalpinx

3. first cycle .

4. Body mass index: 18-29.

5. Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1.

6. Antral follicular count: more than 5 follicles in one ovary.

7. combined factors .

8. 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:

1. Patients with Endometriosis.

2. Azoospermic male.

3. Body mass index more than 29.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Gonadotropin-Releasing Hormone Analogue
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.
• Gonadotropin releasing hormone antagonist
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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of maturated oocyte and good quality embryoes		14 days
Secondary	clinical pregnancy outcome		6 weeks