Here is the design of a clinical trial:

Official Title: Intravenous Immunoglobulin and Prednisolone to Women With Unexplained Recurrent Pregnancy Loss After Assisted Reproductive Technology Treatment: a Randomised, Double-blind, Placebo-controlled Trial

Included conditions:
- Habitual Abortion
- Recurrent Pregnancy Loss
- Fertility Disorders
- Miscarriage

Study Armgroups:
- {'label': 'Active treatment group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intravenous immunoglobulin(IVIg) and prednisolone. IVIG is administered at the time of embryo/blastocyst transfer (ET) (5 days before to 2 days after ET) and if the participant becomes pregnant, the infusion (same dose) is repeated in gestational week 5, 6, and 7.\n\nParticipants with pre-pregnancy weight ≤70 kg will receive 25 g immunoglobulin (250 ml), participants with weight 70-85 kg will receive 30 g immunoglobulin (300 ml), and participants with weight ≥85 kg will receive 35 g immunoglobulin (350 ml) at each infusion, which will approximate 0.4 g IVIg per kg body weight.\n\nPrednisolone, tablets, 5mg. 1 tablet daily started within first 3 days of menstrual cycle and until ET. On the day of ET, the participant will double her dose to 2 tablets daily until a negative pregnancy test, the time of biochemical loss/miscarriage, or pregnancy week 8+0, whichever comes first. Gradual discontinuation four days with one tablet before completing cessation.', 'interventionNames': ['Drug: Human Intravenous Immunoglobulins, (Privigen (R), CLS Behring)', 'Drug: Prednisolone Tablets']}
- {'label': 'Passive treatment group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Human albumin infusion and placebo tablets.\n\nHuman albumin, 5%, (CLS Behring). Participants with pre-pregnancy weight ≤70 kg will receive 250 ml, participants with weight 70-85 kg will receive 300 ml, and participants with weight ≥85 kg will receive 350 ml at each infusion. Administration is planned at the time of ET (5 days before to 2 days after ET) and if the participant becomes pregnant, the infusion is repeated in the same volume in gestational week 5, 6, and 7.\n\nPlacebo tablets: contain 85 mg of lactose monohydrate, 86 mg potato starch, 8.1 mg talc, 3 mg gelatine, and 0.9 mg magnesium stearate. 1 tablet daily started within first 3 days of menstrual cycle and until ET. On the day of ET, the participant will double her dose to 2 tablets daily until a negative pregnancy test, the time of biochemical loss/miscarriage, or pregnancy week 8+0, whichever comes first. Gradual discontinuation four days with one tablet before completing cessation.', 'interventionNames': ['Drug: Human Albumin Solution', 'Drug: Placebo tablet']}

Interventions:
- {'type': 'DRUG', 'name': 'Human Intravenous Immunoglobulins, (Privigen (R), CLS Behring)', 'description': 'infusion: Initial infusion rate of 0.3 ml/kg BW/hr in about 30 min. If well-tolerated, the infusion rate may gradually be increased to 4.8 ml/kg BW/hr. During the infusion, health care personnel are present to secure immediate action in case of serious AR. Blood pressure and pulse is monitored before, during and after the treatment. In case of anaphylaxis, the treatment is discontinued and the participant is excluded. The hospital ward possess adrenaline 0.1 % solutions ready in case of anaphylaxis.', 'armGroupLabels': ['Active treatment group'], 'otherNames': ['IVIg']}
- {'type': 'DRUG', 'name': 'Prednisolone Tablets', 'description': '5 mg before ET and 10 mg after ET until gestational week 8+0', 'armGroupLabels': ['Active treatment group']}
- {'type': 'DRUG', 'name': 'Human Albumin Solution', 'description': 'Infusion: Initial infusion rate of 0.3 ml/kg BW/hr in about 30 min. If well-tolerated, the infusion rate may gradually be increased to 4.8 ml/kg BW/hr. During the infusion, health care personnel are present to secure immediate action in case of serious AR. Blood pressure and pulse is monitored before, during and after the treatment. In case of anaphylaxis, the treatment is discontinued and the participant is excluded. The hospital ward possess adrenaline 0.1 % solutions ready in case of anaphylaxis.', 'armGroupLabels': ['Passive treatment group'], 'otherNames': ['Albumin infusion']}
- {'type': 'DRUG', 'name': 'Placebo tablet', 'description': '1 tablet before ET and 2 tablets after ET until gestational week 8+0', 'armGroupLabels': ['Passive treatment group']}

Primary Outcomes:
- {'measure': 'A normal live fetus at nuchal scan in ITT population', 'description': 'The frequency of participants with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively.\n\nHere, the primary analyses will be undertaken as an intention-to-treat (ITT) analysis, including all participants who were allocated to either active or placebo treatment at the start of the ART cycle, even if they did not receive infusion with IVIg or albumin due to cancellation of embryo/blastocyst transfer.', 'timeFrame': '12 week after embryo transfer'}
- {'measure': 'A normal live fetus at nuchal scan in PP population', 'description': 'The frequency of participants with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively.\n\nHere, the primary analyses will be undertaken as a per-protocol (PP) analysis, including patients who were randomized and received the allocated infusion of study medicine at the time of embryo/blastocyst transfer and had this transfer performed.', 'timeFrame': '12 week after embryo transfer'}
- {'measure': 'Live birth rate in ITT population', 'description': 'The frequency of participants with a liveborn (sign of life immediately af delivery \\>24 weeks) among all randomized participants', 'timeFrame': 'At delivery'}
- {'measure': 'Live birth rate in the PP population', 'description': 'The frequency of participants with a liveborn (sign of life immediately af delivery \\>24 weeks) among all participants who fulfill criteria for PP-analysis', 'timeFrame': 'At delivery'}
- {'measure': 'A normal live fetus at nuchal scan among participants who become pregnant after embryo transfer in the ITT population', 'description': 'The frequency of participants in the ITT population with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively, and who become pregnant after embryo transfer.', 'timeFrame': '12 week after embryo transfer'}
- {'measure': 'A normal live fetus at nuchal scan among participants who become pregnant after embryo transfer in the PP population', 'description': 'The frequency of participants in the PP population with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively, and who become pregnant after embryo transfer.', 'timeFrame': '12 week after embryo transfer'}

Please estimate the sample size based on the assumption: 
A type I error of 0.05, a type II error of 0.20, <2% dropouts, and <10% protocol deviations are expected.
Sample size
        Based on previous studies of similar patients4 5 reporting an live birth rate (LBR) of 36.5% and 34.2% after IVIg and prednisolone treatment, respectively, and an expectation of similar treatment effects in women with 2 and â¥3âPLs, a minimum LBR of 40% in the active treatment group is anticipated. In the RCT by Stephenson and Fluker,28 an LBR of 12% in IVF/ICSI patients with a mean of 3.2 previous failed ETs receiving placebo treatment was reported. The patients admitted to the RPL Clinic within the last 3 years, who would have been eligible for the study, have had a mean of 6.4 previous failed ETs, and we therefore think that a reasonable estimate of the LBR in those of our patients allocated to placebo will be similar to the observed 12%. Based on these expectations, a type I error of 0.05, and a type II error of 0.20, the study will need a sample of 74 participants. Based on experience from previous trials, <2% dropouts and <10% protocol deviations (see figure 2) are expected.
        
          Figure 2
          
            Diagram over the criteria for major protocol deviations. ET, embryo transfer; IV, intravenous.