Effects of Intramural Fibroids on IVF Outcome

Study Overview
=================
Brief Summary
-----------------
A cohort study involving 200 women candidate for IVF / ICSI cycles . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH), , estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.

Detailed Description
-----------------
A cohort study involving 200 women candidate for IVF / ICSI cycles . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH), , estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.

Official Title
-----------------
Effects of Intramural Fibroids That do Not Distort the Uterine Cavity on IVF Outcome

Conditions
-----------------
Infertility, Female, Assisted Reproduction

Intervention / Treatment
-----------------
* Drug: Gonadotropins
* Drug: human chorionic gonadotropin
* Procedure: Ovum pick up
* Procedure: Embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age younger than 40 years FSH) less than 10 IU/L serum prolactin level normal uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography. Exclusion Criteria: abnormal endocrine function (e.g. abnormal thyroid or adrenal function) ovarian cysts, hydrosalpinx endometrial polyps male partner with azoospermia ICSI performed for preimplantation genetic diagnosis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fiboroid group<br>Women with intramural myoma no reaching the cavity | Drug: Gonadotropins<br>* Gonadotropin stimulation of follicular growth<br>* Other names: Ovarian stimulation;Drug: human chorionic gonadotropin<br>* HCG triggering of ovulation<br>* Other names: Triggering of ovulation;Procedure: Ovum pick up<br>* 34 to 36 hours after oocyte retrieval<br>Procedure: Embryo transfer<br>* Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval<br>|
| Active Comparator: Non fibroid group<br>Women without myomas | Drug: Gonadotropins<br>* Gonadotropin stimulation of follicular growth<br>* Other names: Ovarian stimulation;Drug: human chorionic gonadotropin<br>* HCG triggering of ovulation<br>* Other names: Triggering of ovulation;Procedure: Ovum pick up<br>* 34 to 36 hours after oocyte retrieval<br>Procedure: Embryo transfer<br>* Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | appearance of one or more intrauterine gestational sac | 4 weeks after embryo transfer |