Infertility
Conditions
Brief summary
The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve 7eggs only in prevention of severe ovarian hyperstimulation syndrome.
Detailed description
Thirty patients will be selected for this study grouped into two groups, each group contains fifteen patients. Group 1 :study group ( retrieval of 7 eggs only). Group 2 :control group ( retrieval of all eggs). Study is held to compare between the two arms, the proportion of patients who will be prevented from the progression to severe OHSS after this interventional method.
Interventions
PROCEDURE7 eggs collection
vaginal US
PROCEDUREFull eggs collection
vaginal US
Sponsors
Ahmad Hussieny Salama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. More than 9 days of induction of ovulation. 2. Each ovary contains more than 20 follicles. 3. The majority of follicles are \>14mm in diameter. 4. Mild fluid in Douglas pouch. 5. The patient started to complain of considerable lower abdominal pains before the egg collection.
Exclusion criteria
1. Recurrent ICSI failure or bad obstetric history. 2. Any medical disorder affecting the fluid shift as: diabetes mellitus, autoimmune diseases, hepatic, renal or cardiac conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants of Severe Ovarian Hyperstimulation Syndrome | 2 weeks |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 7 Eggs Collection Aspiration of 7 eggs only
7 eggs collection: vaginal US | 15 |
| Full Eggs Collection Aspiration of all eggs
Full eggs collection: vaginal US | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | 7 Eggs Collection | Full Eggs Collection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 7 / 15 |
| serious Total, serious adverse events | 2 / 15 | 7 / 15 |
Outcome results
Primary
Number of Participants of Severe Ovarian Hyperstimulation Syndrome
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7 Eggs Collection | Number of Participants of Severe Ovarian Hyperstimulation Syndrome | 2 participants |
| Full Eggs Collection | Number of Participants of Severe Ovarian Hyperstimulation Syndrome | 11 participants |