Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A5102014 | Other Identifier | Cairo University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In women being treated with medicines to help eggs to grow (called ovulation induction), The investigators wish to know whether adding medicines (called ovulation triggers) that help to release the egg (ovulation) would lead to more women having babies without causing harm compared with not giving them ovulation triggers.
Women will be treated with clomiphene citrate to help eggs to develop to additionally receive a medicine (urinary hCG) to trigger their release or to receive no additional treatment. the investigators tried to determine the benefits and harms of administering an ovulation trigger to anovulatory women receiving treatment with ovulation-inducing agents in comparison with spontaneous ovulation following ovulation induction. so we will have comparison between 2 groups, group 1 will receive clomiphene citrate and trigger ovulation by human chorionic gonadotrophin and group 2 will receive clomiphene citrate with no drug to trigger ovulation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene citrate plus hCG | Active Comparator | Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response could be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size . Women will receive 5,000 IU human chorionic gonadotrophin trigger in the morning between 9 and 10 a.m. and the couple will be advised to have intercourse the following night, about 36 hours later. |
|
| Clomiphene Citrate alone | Active Comparator | Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response will be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size , the women will be advised to have intercourse frequently over the next few days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human chorionic gonadotrophin | Drug | Once a follicle reached more than 18 mm in size,women assigned to group (1) received 5,000 IU hCG trigger in the morning between 9 and 10 a.m. and the couple were advised to have intercourse the following night, about 36 hours later. |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation rate | Collapse of the leading follicle with irregular shape, Appearance of the corpus luteum with diffuse internal echoes. Presence of fluid in the pouch of Douglas or hyperechoic endometrium were taken as supporting features. Serum progesterone levels of more than 10 ng/mL were considered to be evidence of ovulation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| chemical pregnancy | A positive urine pregnancy test done 7 days after missing the period | 1 year |
| Clinical pregnancy | demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation. |
Not provided
Inclusion Criteria:
Normoprolactinemic and normogonadotropic (WHO class II ovarian dysfunction )
Primary infertility with oligomenorrhea (bleeding intervals between 35 days and 6 months) or amenorrhea (bleeding interval more than 6 months)
Age 18-40 years
Duration of primary infertility more than2 years
No history of ovulation induction treatment
No history of thyroid disease
Normal results on hysterosalpingogram
Husband with normal semen analysis
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waleed EL-khayat, M.D. | Contact | 01005135542 | +2 | waleed_elkhyat@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Waleed El-khyatat, M.D. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine , Cairo University | Recruiting | Cairo | Cairo Governorate | 12311 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24482059 | Background | George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| clomiphene citrate alone | Drug | clomiphene citrate alone without hCG trigger |
|
| 1 year |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |