Pregnant Women
Conditions
Brief summary
There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.
Detailed description
The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation. Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval. All patients which show a gestational sac in their uterus in the first US are included in this study and randomized. Inclusion criteria: 1. Patients who underwent ovarian stimulation using GnRH analogues, 2. Fresh embryo transfer, 3. LPS by vaginal micronized P4, 4. Clinical pregnancy demonstrated by US and 5. Informed consent signed. Exclusion criteria: Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
Interventions
OTHERCease progsterone at 5
Cease administration of progsterone at first US at 5 weeks
OTHERcontrol group: progesterone 8
Control group: progesterone until 8 weeks of pregnancy
Sponsors
IVI Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who underwent ovarian stimulation using GnRH analogues, 2. Fresh embryo transfer, 3. LPS by vaginal micronized P4, 4. Clinical pregnancy demonstrated by US and 5. Informed consent signed.
Exclusion criteria
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Bleeding Episodes | Up to year | Number of bleeding episodes up to a year |
Countries
Spain
Participant flow
Recruitment details
Progesterone during 1st trimester
Participants by arm
| Arm | Count |
|---|---|
| Progesterone 5 Weeks The study group of women stop receiving P4 on the day of their first US at 5 weeks pregnancy
Cease progsterone at 5: Cease administration of progsterone at first US at 5 weeks | 100 |
| Control Group : P4 8 Weeks Progesterone will be given until 8 weeks of pregnancy
control group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Progesterone 5 Weeks | Control Group : P4 8 Weeks | 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 | 100 Participants | 100 Participants | 200 Participants |
| Bleeding Episodes | 8 Bleeding episodes STANDARD_DEVIATION 4 | 8 Bleeding episodes STANDARD_DEVIATION 4 | 8 Bleeding episodes STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 100 Participants | 100 Participants | 200 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 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Number of Bleeding Episodes
Number of bleeding episodes up to a year
Time frame: Up to year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group : P4 8 Weeks | Number of Bleeding Episodes | 8 Episodes of bleeding | Standard Deviation 10 |
| Study Group | Number of Bleeding Episodes | 8 Episodes of bleeding | Standard Deviation 10 |